Salivary Gland CarcinomaPhase 2NCT06145308
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
A Phase 2 study testing Cohort 1 (HER2-positive, RC48-ADC), Cohort 2 (NTRK-fusion or NTRK-mutant) and Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone) in people with Salivary Gland Carcinoma and Precision Therapy, run by Peking Union Medical College at 2 sites in China.
Trial summary
Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and safety of precision therapy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Salivary Gland Carcinoma, Precision Therapy
- What is being tested?
- Cohort 1 (HER2-positive, RC48-ADC), Cohort 2 (NTRK-fusion or NTRK-mutant) and Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesChina
- Study dates
- 15 Aug 2023to 10 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histopathologic diagnosis of salivary gland carcinoma
- The tumor tissues were subjected to HER2/NTRK/AR/TROP-2 immunohistochemical staining.
- ECOG physical status 0 or 1 score in the 3 days before the first medication of the study treatment;
- Age 18 or older - no upper limit;
- Life expectancy is more than 3 months; ⑥Have at least one measurable lesion according to RECIST1.1 standards; ⑦Women of childbearing age must have a negative pregnancy test within 7 days before the first medication, and agree to receive the necessary contraceptive measures;
- ⑧The patient must have adequate liver, kidney, bone marrow, heart and lung and other organ functions:
- ⑨Understanding and voluntarily signing informed consent prior to performing any research-related evaluation/operation;
- ⑩Ability to comply with research visit schedules and other programmatic requirements.
Who cannot join
- Known hypersensitivity or delayed anaphylaxis to any agents in this trial;
- Major surgery had been performed within 4 weeks prior to the start of the study and did not fully recover;
- Have received a live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period ;
- To study the occurrence of arterial/venous thrombosis events within 6 months before medication;
- Major cardiovascular diseases;
- Is suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;
- Is suffering from an active infection that requires systemic treatment;
- History of active tuberculosis; ⑨ Positive human immunodeficiency virus (HIV) test result; ⑩ Patients with chronic hepatitis B or active hepatitis C. ⑪Conditions that the investigator believes will affect the safety or compliance of the drug therapy in this study ⑫Female/male who is pregnant or breastfeeding or who intends to give birth;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fei Ma
Beijing, Beijing Municipality, 100021
Fei Ma, MD, +86-10-87787652, drmafei@126.com
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Fei Ma, Dr., 13718455257, drmafei@126.com
About this study
Official title: Cancer Hospital, Chinese Academy of Medical Sciences/National Cancer Center of China
Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and safety of precision therapy.
Read the detailed description
Patients with locally advanced/recurrent or oligometastatic salivary gland carcinoma will be stratified by HER2, NTRK, AR, TROP-2, etc., and receive precision-targeted or chemotherapy regimens, with efficacy (objective response rate, etc.) and safety of neoadjuvant/conversion therapy evaluated.
To assess the efficacy of post-operative adjuvant therapy guided by minimal residual disease (MRD) testing in locally advanced salivary gland carcinoma.
Patients with locally advanced/recurrent or symptomatic, rapidly progressive metastatic salivary gland carcinoma who are intolerant of or refuse surgery and radiotherapy will be molecularly stratified and treated with precision regimens, with efficacy (objective response rate, etc.) and safety of salvage therapy evaluated.
To evaluate efficacy (objective response rate, etc.) and safety of later-line therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma.
Using multi-omic approaches to explore salivary gland carcinoma heterogeneity and biomarkers associated with recurrence, metastasis, treatment response and prognosis.
To investigate concordance between drug-sensitivity testing using ex-vivo 3D tumour models and actual clinical outcomes, and to guide later-line treatment selection based on drug-sensitivity results.
The diagnostic and prognostic value of fibroblast activation protein inhibitor (FAPI) PET/CT for salivary gland cancer: All patients undergo routine standard examinations (FDG PET/CT) and FAPI PET/CT before and after treatment. Two independent blinded reading teams separately evaluate the two sets of images to provide diagnosis, staging, and follow-up on patient prognosis.
- Conditions
- Salivary Gland Carcinoma, Precision Therapy
- Being tested
- Cohort 1 (HER2-positive, RC48-ADC), Cohort 2 (NTRK-fusion or NTRK-mutant), Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone), TROP2 ADC, TKI
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 (HER2-positive, RC48-ADC)Drug
Also called HER2,Vedolizumab
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
Cohort 2 (NTRK-fusion or NTRK-mutant)Drug
Also called NTRK-inhibitor
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)Drug
Also called AR,leuprolide + bicalutamide + abiraterone
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
TROP2 ADCDrug
Also called Cohort 4 (TROP2 ADC)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
TKIDrug
Also called Cohort 5 (ACC-TKI)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
Albumin-paclitaxel + platinumDrug
Also called Cohort 6 (albumin-bound paclitaxel + platinum)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
Albumin-paclitaxel + carboplatin + apatinib + camrelizumabDrug
Also called Cohort 7 (albumin-bound paclitaxel + carboplatin + apatinib + camrelizumab)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
albumin-bound paclitaxel+trastuzumab+pyrotinibDrug
Also called Cohort8 (HER2-positive, albumin-bound paclitaxel + trastuzumab + pyrotinib)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
HER2,trastuzumab deruxtecan± pertuzumabDrug
Also called Cohort9(HER2-positive, DS-8201 ± pertuzumab)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
AR,AR antagonist ++ goserelin + pertuzumab + trastuzumabDrug
Also called Cohort 10 (HER2+/AR+, AR antagonist + goserelin + pertuzumab + trastuzumab)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
AR,AR antagonist +goserelin +docetaxelDrug
Also called Cohort 11 (AR-positive, AR antagonist + goserelin ± docetaxel)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
ivonescimab + investigator-choice platinum doublet+Drug
Also called Cohort 12 (ivonescimab)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
iparomlimab + tuvonralimabDrug
Also called Cohort 13 (iparomlimab + tuvonralimab)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
cadonilimabDrug
Also called Cohort 14 (cadonilimab)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
CDK4/6 inhibitor+AI or fulvestrantDrug
Also called Cohort 15 (HR-positive)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
alpelisib+fulvestrantDrug
Also called Cohort 16 (PI3K-mutant)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
PARP inhibitorDrug
Also called Cohort 17 (homologous-recombination-deficient)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
enfortumab vedotinDrug
Also called Cohort 18 (Nectin-4 ADC)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
HER2, pyrotinib + pertuzumab/trastuzumabDrug
Also called Cohort 19 (HER2-positive, pyrotinib + pertuzumab + trastuzumab)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
vebecotutamab ±lenvatinibDrug
Also called Cohort 20 (vebecotutamab ±lenvatinib)
Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.
Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.
Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (HER2-positive, RC48-ADC) | Experimental | Disitamab vedotin 2.5 mg/kg will be administered as an intravenous infusion every 2 weeks (Q2W) as monotherapy, or in combination with physician-selected platinum-based chemotherapy (carboplatin 200-250 mg/m² IV Q2W or cisplatin 50 mg/m² IV Q2W). Receives: Drug: Cohort 1 (HER2-positive, RC48-ADC) |
| Cohort 2 (NTRK-fusion or NTRK-mutant) | Experimental | larotrectinib 100 mg orally twice daily or entrectinib 600 mg orally once daily; Receives: Drug: Cohort 2 (NTRK-fusion or NTRK-mutant) |
| Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone) | Experimental | leuprolide 3.75 mg subcutaneously every 4 weeks, bicalutamide 50 mg orally once daily, and abiraterone 1 000 mg orally once daily. Receives: Drug: Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone) |
| Cohort 4 (TROP2 ADC) | Experimental | ESG401 16 mg/kg IV (days 1, 8, 15, q4w), sacituzumab govitecan 10 mg/kg IV (days 1 \& 8, q3w), or sacituzumab tirumotecan 5 mg/kg IV q2w. Receives: Drug: TROP2 ADC |
| Cohort 5 (ACC-TKI) | Experimental | apatinib 250 mg qd po or anlotinib 12 mg Receives: Drug: TKI |
| Cohort 6 (albumin-bound paclitaxel + platinum) | Experimental | albumin-bound paclitaxel 260 mg/m² IV q3w plus physician-selected cisplatin 75 mg/m² IV q3w or carboplatin 350 mg/m² IV q3w. Receives: Drug: Albumin-paclitaxel + platinum |
| Cohort 7 (albumin-bound paclitaxel + carboplatin + apatinib + camrelizumab) | Experimental | albumin-bound paclitaxel 260 mg/m² IV q3w, carboplatin 350 mg/m² IV q3w, camrelizumab 200 mg IV q3w, and apatinib 250 mg qd po. Receives: Drug: Albumin-paclitaxel + carboplatin + apatinib + camrelizumab |
| Cohort 8 (HER2-positive, albumin-bound paclitaxel + trastuzumab + pyrotinib) | Experimental | albumin-bound paclitaxel 260 mg/m² + trastuzumab (loading 8 mg/kg → 6 mg/kg IV q3w) + pyrotinib 400 mg PO qd. Receives: Drug: albumin-bound paclitaxel+trastuzumab+pyrotinib |
| Cohort 9 (HER2-positive, DS-8201 ± pertuzumab) | Experimental | trastuzumab deruxtecan 5.4 mg/kg IV q3w ± pertuzumab (loading 840 mg → 420 mg IV q3w). Receives: Drug: HER2,trastuzumab deruxtecan± pertuzumab |
| Cohort 10 (HER2+/AR+, AR antagonist + goserelin + pertuzumab + trastuzumab) | Experimental | Darolutamide 600mg po bid / Enzalutamide 160mg po qd / Apalutamide 240mg po qd / Rivarutamide 240mg po qd + goserelin 10.8 mg SC q12w + pertuzumab/trastuzumab loading 15 mL → 10 mL SC q3w. Receives: Drug: AR,AR antagonist ++ goserelin + pertuzumab + trastuzumab |
| Cohort 11 (AR-positive, AR antagonist+ goserelin ± docetaxel) | Experimental | Darolutamide 600mg po bid / Enzalutamide 160mg po qd / Apalutamide 240mg po qd / Rivarutamide 240mg po qd+ goserelin 10.8 mg SC q12w ± docetaxel 75 mg/m² IV q3w. Receives: Drug: AR,AR antagonist +goserelin +docetaxel |
| Cohort 12 (ivonescimab) | Experimental | ivonescimab 20 mg/kg + investigator-choice platinum doublet (albumin-paclitaxel 260 mg/m², liposomal paclitaxel 175 mg/m², docetaxel 75 mg/m², or vinorelbine 25 mg/m² d1,d8) plus cisplatin 75 mg/m² or carboplatin AUC 5-6 IV q3w. Receives: Drug: ivonescimab + investigator-choice platinum doublet+ |
| Cohort 13 (iparomlimab + tuvonralimab) | Experimental | iparomlimab 5 mg/kg + platinum doublet (as above) ± bevacizumab 5 mg/kg IV q3w. Receives: Drug: iparomlimab + tuvonralimab |
| Cohort 14 (cadonilimab) | Experimental | cadonilimab 10 mg/kg + platinum doublet (as above) ± bevacizumab 5 mg/kg IV q3w. Receives: Drug: cadonilimab |
| Cohort 15 (HR-positive) | Experimental | CDK4/6 inhibitor (abemaciclib 150 mg PO bid or palbociclib 125 mg PO qd) plus AI (letrozole 2.5 mg, anastrozole 1 mg, or exemestane 20 mg PO qd) or fulvestrant 500 mg IM q4w Receives: Drug: CDK4/6 inhibitor+AI or fulvestrant |
| Cohort 16 (PI3K-mutant) | Experimental | alpelisib 300 mg PO qd plus fulvestrant 500 mg IM q4w. Receives: Drug: alpelisib+fulvestrant |
| Cohort 17 (homologous-recombination-deficient) | Experimental | PARP inhibitor (olaparib 300 mg PO bid, niraparib 300 mg PO qd, fluzoparib 150 mg PO bid, or pamiparib 60 mg PO bid). Receives: Drug: PARP inhibitor |
| Cohort 18 (Nectin-4 ADC) | Experimental | enfortumab vedotin 1.25 mg/kg IV d1,d8,d15 (max 125 mg) ± ICI (pembrolizumab 200 mg, camrelizumab 200 mg, or toripalimab 240 mg IV q3w). Receives: Drug: enfortumab vedotin |
| Cohort 19 (HER2-positive, pyrotinib + pertuzumab + trastuzumab) | Experimental | pyrotinib 400 mg PO qd + pertuzumab/trastuzumab loading 15 mL → 10 mL SC q3w. Receives: Drug: HER2, pyrotinib + pertuzumab/trastuzumab |
| ⑳ Cohort 20 (vebecotutamab ±lenvatinib): | Experimental | verbecotutamab 2.0 mg/kg ivgtt ± lenvatinib 8mg qd q3w Receives: Drug: vebecotutamab ±lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
ORR rates for neoadjuvant and translational therapy in patients with locally advanced/recurrent and advanced oligometastatic salivary gland cancer and ORR rate of salvage therapy for locally advanced/recurrent or distantly metastatic salivary gland carcinoma with rapid progression that cannot tolerate or refuses surgery
Measured: ORR at the end of Cycle 2 (each cycle is 21 days)
Secondary outcomes (6)
MPR;
MPR rates in patients who received neoadjuvant and translational therapy and then underwent surgery
Measured: MPR rate at the end of surgical treatment
R0 resection rate;
R0 resection rate in patients who received neoadjuvant and translational therapy and then underwent surgery
Measured: R0 resection rate at the end of surgical treatment
Facial nerve protection rate
Facial nerve protection rate in patients who received neoadjuvant and translational therapy and then underwent surgery
Measured: Facial nerve protection rate at the end of surgical treatment
DFS
3-year DFS rates for patients who underwent surgery
Measured: DFS rates at 3-year
PFS;
2-Year PFS Rate for Patients Receiving Rescue Therapy
Measured: PFS Rate at 2-Year
OS
OS for all patients
Measured: OS rate at 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start15 Aug 2023
- Primary completion10 Jul 2028 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study employs a master-protocol platform design with the primary objective of identifying promising subgroups; new drug regimens may be added during the trial, while ineffective arms are closed based on interim monitoring. The trial consists of two stages. In Stage 1, each experimental arm uses a Bayesian Optimal Phase II (BOP2) design to assess whether the regimen shows sufficient efficacy to warrant further investigation. Arms demonstrating promising activity proceed to Stage 2（Simon two-stage design）.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Hospital of Stomatology
- Responsible party
- Principal investigator, Fei Ma, Peking Union Medical College
- Investigators
- Jie Zhang, Principal investigator, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145308
- Sponsor's protocol ID
- NCC4132
- Status last verified
- Mar 2026
- First submitted
- 7 Sep 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Hospital, Chinese Academy of Medical Sciences/National Cancer Center of China
- ClinicalTrials.gov ID
- NCT06145308
- Acronym / sponsor ID
- NCC4132
- Conditions
- Salivary Gland Carcinoma, Precision Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- Peking University Hospital of Stomatology
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 10 Jul 2028 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and safety of precision therapy.
Detailed description
Patients with locally advanced/recurrent or oligometastatic salivary gland carcinoma will be stratified by HER2, NTRK, AR, TROP-2, etc., and receive precision-targeted or chemotherapy regimens, with efficacy (objective response rate, etc.) and safety of neoadjuvant/conversion therapy evaluated.
To assess the efficacy of post-operative adjuvant therapy guided by minimal residual disease (MRD) testing in locally advanced salivary gland carcinoma.
Patients with locally advanced/recurrent or symptomatic, rapidly progressive metastatic salivary gland carcinoma who are intolerant of or refuse surgery and radiotherapy will be molecularly stratified and treated with precision regimens, with efficacy (objective response rate, etc.) and safety of salvage therapy evaluated.
To evaluate efficacy (objective response rate, etc.) and safety of later-line therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma.
Using multi-omic approaches to explore salivary gland carcinoma heterogeneity and biomarkers associated with recurrence, metastasis, treatment response and prognosis.
To investigate concordance between drug-sensitivity testing using ex-vivo 3D tumour models and actual clinical outcomes, and to guide later-line treatment selection based on drug-sensitivity results.
The diagnostic and prognostic value of fibroblast activation protein inhibitor (FAPI) PET/CT for salivary gland cancer: All patients undergo routine standard examinations (FDG PET/CT) and FAPI PET/CT before and after treatment. Two independent blinded reading teams separately evaluate the two sets of images to provide diagnosis, staging, and follow-up on patient prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 20
- Model description
- The study employs a master-protocol platform design with the primary objective of identifying promising subgroups; new drug regimens may be added during the trial, while ineffective arms are closed based on interim monitoring. The trial consists of two stages. In Stage 1, each experimental arm uses a Bayesian Optimal Phase II (BOP2) design to assess whether the regimen shows sufficient efficacy to warrant further investigation. Arms demonstrating promising activity proceed to Stage 2（Simon two-stage design）.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (HER2-positive, RC48-ADC) | Experimental | Drug: Cohort 1 (HER2-positive, RC48-ADC)Disitamab vedotin 2.5 mg/kg will be administered as an intravenous infusion every 2 weeks (Q2W) as monotherapy, or in combination with physician-selected platinum-based chemotherapy (carboplatin 200-250 mg/m² IV Q2W or cisplatin 50 mg/m² IV Q2W). |
| Cohort 2 (NTRK-fusion or NTRK-mutant) | Experimental | Drug: Cohort 2 (NTRK-fusion or NTRK-mutant)larotrectinib 100 mg orally twice daily or entrectinib 600 mg orally once daily; |
| Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone) | Experimental | Drug: Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)leuprolide 3.75 mg subcutaneously every 4 weeks, bicalutamide 50 mg orally once daily, and abiraterone 1 000 mg orally once daily. |
| Cohort 4 (TROP2 ADC) | Experimental | Drug: TROP2 ADCESG401 16 mg/kg IV (days 1, 8, 15, q4w), sacituzumab govitecan 10 mg/kg IV (days 1 \& 8, q3w), or sacituzumab tirumotecan 5 mg/kg IV q2w. |
| Cohort 5 (ACC-TKI) | Experimental | Drug: TKIapatinib 250 mg qd po or anlotinib 12 mg |
| Cohort 6 (albumin-bound paclitaxel + platinum) | Experimental | Drug: Albumin-paclitaxel + platinumalbumin-bound paclitaxel 260 mg/m² IV q3w plus physician-selected cisplatin 75 mg/m² IV q3w or carboplatin 350 mg/m² IV q3w. |
| Cohort 7 (albumin-bound paclitaxel + carboplatin + apatinib + camrelizumab) | Experimental | Drug: Albumin-paclitaxel + carboplatin + apatinib + camrelizumabalbumin-bound paclitaxel 260 mg/m² IV q3w, carboplatin 350 mg/m² IV q3w, camrelizumab 200 mg IV q3w, and apatinib 250 mg qd po. |
| Cohort 8 (HER2-positive, albumin-bound paclitaxel + trastuzumab + pyrotinib) | Experimental | Drug: albumin-bound paclitaxel+trastuzumab+pyrotinibalbumin-bound paclitaxel 260 mg/m² + trastuzumab (loading 8 mg/kg → 6 mg/kg IV q3w) + pyrotinib 400 mg PO qd. |
| Cohort 9 (HER2-positive, DS-8201 ± pertuzumab) | Experimental | Drug: HER2,trastuzumab deruxtecan± pertuzumabtrastuzumab deruxtecan 5.4 mg/kg IV q3w ± pertuzumab (loading 840 mg → 420 mg IV q3w). |
| Cohort 10 (HER2+/AR+, AR antagonist + goserelin + pertuzumab + trastuzumab) | Experimental | Drug: AR,AR antagonist ++ goserelin + pertuzumab + trastuzumabDarolutamide 600mg po bid / Enzalutamide 160mg po qd / Apalutamide 240mg po qd / Rivarutamide 240mg po qd + goserelin 10.8 mg SC q12w + pertuzumab/trastuzumab loading 15 mL → 10 mL SC q3w. |
| Cohort 11 (AR-positive, AR antagonist+ goserelin ± docetaxel) | Experimental | Drug: AR,AR antagonist +goserelin +docetaxelDarolutamide 600mg po bid / Enzalutamide 160mg po qd / Apalutamide 240mg po qd / Rivarutamide 240mg po qd+ goserelin 10.8 mg SC q12w ± docetaxel 75 mg/m² IV q3w. |
| Cohort 12 (ivonescimab) | Experimental | Drug: ivonescimab + investigator-choice platinum doublet+ivonescimab 20 mg/kg + investigator-choice platinum doublet (albumin-paclitaxel 260 mg/m², liposomal paclitaxel 175 mg/m², docetaxel 75 mg/m², or vinorelbine 25 mg/m² d1,d8) plus cisplatin 75 mg/m² or carboplatin AUC 5-6 IV q3w. |
| Cohort 13 (iparomlimab + tuvonralimab) | Experimental | Drug: iparomlimab + tuvonralimabiparomlimab 5 mg/kg + platinum doublet (as above) ± bevacizumab 5 mg/kg IV q3w. |
| Cohort 14 (cadonilimab) | Experimental | Drug: cadonilimabcadonilimab 10 mg/kg + platinum doublet (as above) ± bevacizumab 5 mg/kg IV q3w. |
| Cohort 15 (HR-positive) | Experimental | Drug: CDK4/6 inhibitor+AI or fulvestrantCDK4/6 inhibitor (abemaciclib 150 mg PO bid or palbociclib 125 mg PO qd) plus AI (letrozole 2.5 mg, anastrozole 1 mg, or exemestane 20 mg PO qd) or fulvestrant 500 mg IM q4w |
| Cohort 16 (PI3K-mutant) | Experimental | Drug: alpelisib+fulvestrantalpelisib 300 mg PO qd plus fulvestrant 500 mg IM q4w. |
| Cohort 17 (homologous-recombination-deficient) | Experimental | Drug: PARP inhibitorPARP inhibitor (olaparib 300 mg PO bid, niraparib 300 mg PO qd, fluzoparib 150 mg PO bid, or pamiparib 60 mg PO bid). |
| Cohort 18 (Nectin-4 ADC) | Experimental | Drug: enfortumab vedotinenfortumab vedotin 1.25 mg/kg IV d1,d8,d15 (max 125 mg) ± ICI (pembrolizumab 200 mg, camrelizumab 200 mg, or toripalimab 240 mg IV q3w). |
| Cohort 19 (HER2-positive, pyrotinib + pertuzumab + trastuzumab) | Experimental | Drug: HER2, pyrotinib + pertuzumab/trastuzumabpyrotinib 400 mg PO qd + pertuzumab/trastuzumab loading 15 mL → 10 mL SC q3w. |
| ⑳ Cohort 20 (vebecotutamab ±lenvatinib): | Experimental | Drug: vebecotutamab ±lenvatinibverbecotutamab 2.0 mg/kg ivgtt ± lenvatinib 8mg qd q3w |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histopathologic diagnosis of salivary gland carcinoma
- ⑧The patient must have adequate liver, kidney, bone marrow, heart and lung and other organ functions:
- ⑨Understanding and voluntarily signing informed consent prior to performing any research-related evaluation/operation;
- ⑩Ability to comply with research visit schedules and other programmatic requirements.
Key exclusion criteria (8 listed)
- Known hypersensitivity or delayed anaphylaxis to any agents in this trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1 (HER2-positive, RC48-ADC)Also: HER2,VedolizumabNeoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 1 (HER2-positive, RC48-ADC) |
| Cohort 2 (NTRK-fusion or NTRK-mutant)Also: NTRK-inhibitorNeoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 2 (NTRK-fusion or NTRK-mutant) |
| Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)Also: AR,leuprolide + bicalutamide + abirateroneNeoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone) |
| TROP2 ADCAlso: Cohort 4 (TROP2 ADC)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 4 (TROP2 ADC) |
| TKIAlso: Cohort 5 (ACC-TKI)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 5 (ACC-TKI) |
| Albumin-paclitaxel + platinumAlso: Cohort 6 (albumin-bound paclitaxel + platinum)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 6 (albumin-bound paclitaxel + platinum) |
| Albumin-paclitaxel + carboplatin + apatinib + camrelizumabAlso: Cohort 7 (albumin-bound paclitaxel + carboplatin + apatinib + camrelizumab)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 7 (albumin-bound paclitaxel + carboplatin + apatinib + camrelizumab) |
| albumin-bound paclitaxel+trastuzumab+pyrotinibAlso: Cohort8 (HER2-positive, albumin-bound paclitaxel + trastuzumab + pyrotinib)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 8 (HER2-positive, albumin-bound paclitaxel + trastuzumab + pyrotinib) |
| HER2,trastuzumab deruxtecan± pertuzumabAlso: Cohort9(HER2-positive, DS-8201 ± pertuzumab)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 9 (HER2-positive, DS-8201 ± pertuzumab) |
| AR,AR antagonist ++ goserelin + pertuzumab + trastuzumabAlso: Cohort 10 (HER2+/AR+, AR antagonist + goserelin + pertuzumab + trastuzumab)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 10 (HER2+/AR+, AR antagonist + goserelin + pertuzumab + trastuzumab) |
| AR,AR antagonist +goserelin +docetaxelAlso: Cohort 11 (AR-positive, AR antagonist + goserelin ± docetaxel)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 11 (AR-positive, AR antagonist+ goserelin ± docetaxel) |
| ivonescimab + investigator-choice platinum doublet+Also: Cohort 12 (ivonescimab)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 12 (ivonescimab) |
| iparomlimab + tuvonralimabAlso: Cohort 13 (iparomlimab + tuvonralimab)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 13 (iparomlimab + tuvonralimab) |
| cadonilimabAlso: Cohort 14 (cadonilimab)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 14 (cadonilimab) |
| CDK4/6 inhibitor+AI or fulvestrantAlso: Cohort 15 (HR-positive)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 15 (HR-positive) |
| alpelisib+fulvestrantAlso: Cohort 16 (PI3K-mutant)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 16 (PI3K-mutant) |
| PARP inhibitorAlso: Cohort 17 (homologous-recombination-deficient)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 17 (homologous-recombination-deficient) |
| enfortumab vedotinAlso: Cohort 18 (Nectin-4 ADC)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 18 (Nectin-4 ADC) |
| HER2, pyrotinib + pertuzumab/trastuzumabAlso: Cohort 19 (HER2-positive, pyrotinib + pertuzumab + trastuzumab)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | Cohort 19 (HER2-positive, pyrotinib + pertuzumab + trastuzumab) |
| vebecotutamab ±lenvatinibAlso: Cohort 20 (vebecotutamab ±lenvatinib)Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate. | Drug | ⑳ Cohort 20 (vebecotutamab ±lenvatinib): |
Primary outcome
ORR
Time frame: ORR at the end of Cycle 2 (each cycle is 21 days)
ORR rates for neoadjuvant and translational therapy in patients with locally advanced/recurrent and advanced oligometastatic salivary gland cancer and ORR rate of salvage therapy for locally advanced/recurrent or distantly metastatic salivary gland carcinoma with rapid progression that cannot tolerate or refuses surgery
6 secondary outcomes
MPR;
Time frame: MPR rate at the end of surgical treatment
R0 resection rate;
Time frame: R0 resection rate at the end of surgical treatment
Facial nerve protection rate
Time frame: Facial nerve protection rate at the end of surgical treatment
DFS
Time frame: DFS rates at 3-year
PFS;
Time frame: PFS Rate at 2-Year
OS
Time frame: OS rate at 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jie Zhang principal investigator
Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cohort 1 (HER2-positive, RC48-ADC), Cohort 2 (NTRK-fusion or NTRK-mutant) and Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone) in people with Salivary Gland Carcinoma and Precision Therapy, run by Peking Union Medical College at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact fei Ma (13910217780, drmafei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: ORR at the end of Cycle 2 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.