Head and Neck Squamous Cell CarcinomaPhase 2NCT06016413
Adelbelimab Combination Chemotherapy in Neoadjuvant Therapy for Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing Nab paclitaxel, Carboplatin and adelbelimumab in people with Head and Neck Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study explored the efficacy of adelbelimab (PD-L1 inhibitor) combined with chemotherapy in preoperative induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nab paclitaxel, Carboplatin and adelbelimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-75 years old
- According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVB tumors of non-oropharyngeal cancers confirmed by pathology as head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx) and HPV-negative oropharyngeal cancer patients, or HPV-positive oropharyngeal cancer patients with stage II-III tumors
- Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis
- According to RECIST 1.1, there is at least one measurable tumor lesion
- The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1
- Blood routine: white blood cell count (WBC) ≥ 3.0×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/L; platelet (PLT) ≥ 100×109/L; hemoglobin level (HGB) ≥ 9.0 g/dL (without corresponding supportive treatment such as blood transfusion and leukocytosis within 7 days).
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- Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in patients without liver metastasis ≤ 2.5 times the upper limit of the reference value (ULN); albumin (ALB) ≥ 30 g /L.
- Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance (CrCl) ≥ 50mL/min (using the Cockcroft/Galter formula); urine protein (UPRO) < (++), or 24 Hourly urine protein < 1.0 g.
- Determination of HPV status in oropharyngeal cancers using p16 IHC. A sample was considered p16 positive if >70% of tumor cells exhibited intense diffuse nuclear and cytoplasmic staining
- Have not participated in other clinical trial projects in the past 30 days;
- Patients who voluntarily participate in the project and sign the informed consent.
Who cannot join
- The patient has abnormal blood indicators, abnormal liver and kidney function, and cannot tolerate the clinical research process after multidisciplinary consultation evaluation
- The patient has previously suffered from other tumors, or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy
- The entire clinical research process cannot be completed due to personal, social and economic reasons
- Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Zhiquan Huang, 02081332471, hzhquan@mail.sysu.edu.cn
About this study
Official title: A Prospective, Single-arm, Phase II Study of Adelbelimab Combined With Carboplatin and Nab-paclitaxel in Neoadjuvant Therapy for Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck
This study explored the efficacy of adelbelimab (PD-L1 inhibitor) combined with chemotherapy in preoperative induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
Read the detailed description
According to the latest data from the International Agency for Research on Cancer, the new incidence of head and neck cancer in the world in 2022 will be among the top ten new incidences of cancer in the world. In the latest WHO classification of head and neck tumors, head and neck cancers include nasopharyngeal cancer, oral cavity cancer, oropharyngeal cancer, thyroid cancer, laryngeal cancer and other malignant tumors that occur in the head and neck, of which more than 90% are squamous cells cancer. Currently, the standard of care for locally advanced head and neck squamous cell carcinoma (HNSCC) is surgical resection followed by risk-adapted adjuvant radiotherapy, with or without platinum-based chemotherapy, or definitive concurrent chemoradiotherapy. With this aggressive combination therapy, the risk of recurrence, distant metastasis, and death remains high in patients with locally advanced human papillomavirus (HPV)-negative HNSCC. In terms of preoperative induction chemotherapy, clinical studies have shown that patients with tumor remission after preoperative induction chemotherapy have a higher survival rate and a lower risk of distant metastasis, but the postoperative pathological complete remission rate of the tumor is lower , it is difficult to be satisfactory. With the rise of tumor immunology, more and more immunotherapy methods are applied to the clinical treatment of tumors. Current immunotherapies come in many forms, including immune checkpoint inhibitors, co-stimulatory point agonists, antigen vaccines, oncolytic virus therapy, adoptive T cell transfer (ACT) and epidermal growth factor receptor ( Epidermal growth factor receptor, EGFR) targeted therapy. Among them, immune checkpoint inhibitors have been widely used in the clinical treatment of tumors, and the molecular mechanisms of immune checkpoints (immune checkpoint inhibitors, ICIs) are mainly such as programmed cell death 1 (PD-1) and cytotoxic T lymphocytes. Cellular antigen 4 (CTLA-4) is a co-inhibitory receptor expressed on the surface of T cells to negatively regulate T cell-mediated immune responses; however, tumor cells utilize these inhibitory molecules to induce tumor tolerance and T cell exhaustion. Therefore, ICIs such as anti-CTLA-4, anti-PD-1, and anti-PD-L1 can attach to these co-inhibitory receptors to reactivate the immune response against tumor cells. In head and neck squamous cell carcinoma, immune checkpoint inhibitors have been widely used clinically, among which PD-1 inhibitors are the most widely used. A clinical study (KEYNOTE-048) showed that pembrolizumab combined with chemotherapy can significantly improve the survival time of recurrent and metastatic head and neck squamous cell carcinoma. And this is also included in the first-line recommendation of the NCCN guidelines for the treatment of patients with recurrent and metastatic head and neck squamous cell carcinoma. In terms of preoperative neoadjuvant chemotherapy for head and neck squamous cell carcinoma, camrelizumab combined with chemotherapy neoadjuvant chemotherapy in the treatment of locally advanced HNSCC showed high objective response rate and pathological response rate. PD-L1 and PD-L2 are two ligands of PD-1. Both tumor and immune cells can express PD-L1, and PD-L1 is a useful biomarker to predict the response to PD-1/PD-L1 antibodies in patients with different types of cancer. PD-L1 plays a role in inhibiting the cancer-immune cycle by binding to negative regulators of T cell activation such as PD-1 and B7.1. However, PD-L1 inhibitors are currently less used in clinical tumor treatment, mainly focusing on small cell lung cancer. Among them, adelbelimab is a human monoclonal antibody against programmed death ligand 1 (PD-L1), and its safety has been verified to some extent. In a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, the median follow-up time of the test group was 13.5 months and the placebo group was 12.8 months; the hazard ratio was 0.72 [95% confidence interval 0.58-0.90]; Compared with one-sided p=0.017), the median overall survival rate of the adelbelimab group was significantly improved (median 15.3 months [95% CI 13.2-17.5]) . In terms of head and neck squamous cell carcinoma, only phase I clinical studies have confirmed the safety and tumor activity of PD-L1 inhibitors in treatment. On this basis, this study will further verify the efficacy of preoperative neoadjuvant chemotherapy in patients with resectable locally advanced head and neck squamous cell carcinoma with PD-L1 inhibitors combined with chemotherapy.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Nab paclitaxel, Carboplatin, adelbelimumab
- Keywords
- head and neck squamous cell carcinoma, immunity therapy, PD-L1
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxelDrug
All patients received nab-paclitaxel 260 mg/m2 intravenously on day 1 of each 3-week cycle for 3 cycles.
CarboplatinDrug
All patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles.
adelbelimumabDrug
All patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | All patients received nab-paclitaxel 260 mg/m2, carboplatin AUC=5 and adelbelimumab 1200 mg intravenously on day 1 of each 3-week cycle for 3 cycles. All patients were given conventional drugs to prevent vomiting in each cycle, and intravenous dexamethasone was given to prevent allergy before each dose Receives: Drug: Nab paclitaxel; Drug: Carboplatin; Drug: adelbelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pathological complete response rate
The postoperative specimens were sent to the pathology department for fixation, sectioning, and observation. Two pathologists judge whether the subject's tumor remains. If there is a disagreement between the two, the third senior pathologist will discuss and decide
Measured: one week after operative
Secondary outcomes (2)
Major pathological response rate
The postoperative specimens were sent to the pathology department for fixation, sectioning, and observation. Two pathologists judge whether the subject's tumor remains. If there is a disagreement between the two, the third senior pathologist will discuss and decide
Measured: one week after operative
Two years overall Survival
Measured: Two years after investigator enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016413
- Sponsor's protocol ID
- SYSKY-2023-616-02
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Colevas AD, Bahleda R, Braiteh F, Balmanoukian A, Brana I, Chau NG, Sarkar I, Molinero L, Grossman W, Kabbinavar F, Fasso M, O'Hear C, Powderly J. Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. Ann Oncol. 2018 Nov 1;29(11):2247-2253. doi: 10.1093/annonc/mdy411.
PubMed 30219915Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.
PubMed 35576956Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.
PubMed 25428504Doroshow DB, Bhalla S, Beasley MB, Sholl LM, Kerr KM, Gnjatic S, Wistuba II, Rimm DL, Tsao MS, Hirsch FR. PD-L1 as a biomarker of response to immune-checkpoint inhibitors. Nat Rev Clin Oncol. 2021 Jun;18(6):345-362. doi: 10.1038/s41571-021-00473-5. Epub 2021 Feb 12.
PubMed 33580222Wu Y, Chen W, Xu ZP, Gu W. PD-L1 Distribution and Perspective for Cancer Immunotherapy-Blockade, Knockdown, or Inhibition. Front Immunol. 2019 Aug 27;10:2022. doi: 10.3389/fimmu.2019.02022. eCollection 2019.
PubMed 31507611Zhang Z, Wu B, Peng G, Xiao G, Huang J, Ding Q, Yang C, Xiong X, Ma H, Shi L, Yang J, Hong X, Wei J, Qin Y, Wan C, Zhong Y, Zhou Y, Zhao X, Leng Y, Zhang T, Wu G, Yao M, Zhang X, Yang K. Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial. Clin Cancer Res. 2022 Aug 2;28(15):3268-3276. doi: 10.1158/1078-0432.CCR-22-0666.
PubMed 35766967Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.
PubMed 31679945Seidel JA, Otsuka A, Kabashima K. Anti-PD-1 and Anti-CTLA-4 Therapies in Cancer: Mechanisms of Action, Efficacy, and Limitations. Front Oncol. 2018 Mar 28;8:86. doi: 10.3389/fonc.2018.00086. eCollection 2018.
PubMed 29644214Sadeghi Rad H, Monkman J, Warkiani ME, Ladwa R, O'Byrne K, Rezaei N, Kulasinghe A. Understanding the tumor microenvironment for effective immunotherapy. Med Res Rev. 2021 May;41(3):1474-1498. doi: 10.1002/med.21765. Epub 2020 Dec 4.
PubMed 33277742Yu C, Li Q, Zhang Y, Wen ZF, Dong H, Mou Y. Current status and perspective of tumor immunotherapy for head and neck squamous cell carcinoma. Front Cell Dev Biol. 2022 Aug 26;10:941750. doi: 10.3389/fcell.2022.941750. eCollection 2022.
PubMed 36092724Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Wang LZ, Fan XD, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Wang BS, Kies MS, Lee JJ, Myers JN, Zhang ZY. Randomized phase III trial of induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery versus up-front surgery in locally advanced resectable oral squamous cell carcinoma. J Clin Oncol. 2013 Feb 20;31(6):744-51. doi: 10.1200/JCO.2012.43.8820. Epub 2012 Nov 5.
PubMed 23129742Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.
PubMed 15128894Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.
PubMed 15128893Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
PubMed 35020204
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Phase II Study of Adelbelimab Combined With Carboplatin and Nab-paclitaxel in Neoadjuvant Therapy for Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT06016413
- Acronym / sponsor ID
- SYSKY-2023-616-02
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck squamous cell carcinoma, immunity therapy, PD-L1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Aug 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.
This study explored the efficacy of adelbelimab (PD-L1 inhibitor) combined with chemotherapy in preoperative induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
Detailed description
According to the latest data from the International Agency for Research on Cancer, the new incidence of head and neck cancer in the world in 2022 will be among the top ten new incidences of cancer in the world. In the latest WHO classification of head and neck tumors, head and neck cancers include nasopharyngeal cancer, oral cavity cancer, oropharyngeal cancer, thyroid cancer, laryngeal cancer and other malignant tumors that occur in the head and neck, of which more than 90% are squamous cells cancer. Currently, the standard of care for locally advanced head and neck squamous cell carcinoma (HNSCC) is surgical resection followed by risk-adapted adjuvant radiotherapy, with or without platinum-based chemotherapy, or definitive concurrent chemoradiotherapy. With this aggressive combination therapy, the risk of recurrence, distant metastasis, and death remains high in patients with locally advanced human papillomavirus (HPV)-negative HNSCC. In terms of preoperative induction chemotherapy, clinical studies have shown that patients with tumor remission after preoperative induction chemotherapy have a higher survival rate and a lower risk of distant metastasis, but the postoperative pathological complete remission rate of the tumor is lower , it is difficult to be satisfactory. With the rise of tumor immunology, more and more immunotherapy methods are applied to the clinical treatment of tumors. Current immunotherapies come in many forms, including immune checkpoint inhibitors, co-stimulatory point agonists, antigen vaccines, oncolytic virus therapy, adoptive T cell transfer (ACT) and epidermal growth factor receptor ( Epidermal growth factor receptor, EGFR) targeted therapy. Among them, immune checkpoint inhibitors have been widely used in the clinical treatment of tumors, and the molecular mechanisms of immune checkpoints (immune checkpoint inhibitors, ICIs) are mainly such as programmed cell death 1 (PD-1) and cytotoxic T lymphocytes. Cellular antigen 4 (CTLA-4) is a co-inhibitory receptor expressed on the surface of T cells to negatively regulate T cell-mediated immune responses; however, tumor cells utilize these inhibitory molecules to induce tumor tolerance and T cell exhaustion. Therefore, ICIs such as anti-CTLA-4, anti-PD-1, and anti-PD-L1 can attach to these co-inhibitory receptors to reactivate the immune response against tumor cells. In head and neck squamous cell carcinoma, immune checkpoint inhibitors have been widely used clinically, among which PD-1 inhibitors are the most widely used. A clinical study (KEYNOTE-048) showed that pembrolizumab combined with chemotherapy can significantly improve the survival time of recurrent and metastatic head and neck squamous cell carcinoma. And this is also included in the first-line recommendation of the NCCN guidelines for the treatment of patients with recurrent and metastatic head and neck squamous cell carcinoma. In terms of preoperative neoadjuvant chemotherapy for head and neck squamous cell carcinoma, camrelizumab combined with chemotherapy neoadjuvant chemotherapy in the treatment of locally advanced HNSCC showed high objective response rate and pathological response rate. PD-L1 and PD-L2 are two ligands of PD-1. Both tumor and immune cells can express PD-L1, and PD-L1 is a useful biomarker to predict the response to PD-1/PD-L1 antibodies in patients with different types of cancer. PD-L1 plays a role in inhibiting the cancer-immune cycle by binding to negative regulators of T cell activation such as PD-1 and B7.1. However, PD-L1 inhibitors are currently less used in clinical tumor treatment, mainly focusing on small cell lung cancer. Among them, adelbelimab is a human monoclonal antibody against programmed death ligand 1 (PD-L1), and its safety has been verified to some extent. In a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, the median follow-up time of the test group was 13.5 months and the placebo group was 12.8 months; the hazard ratio was 0.72 [95% confidence interval 0.58-0.90]; Compared with one-sided p=0.017), the median overall survival rate of the adelbelimab group was significantly improved (median 15.3 months [95% CI 13.2-17.5]) . In terms of head and neck squamous cell carcinoma, only phase I clinical studies have confirmed the safety and tumor activity of PD-L1 inhibitors in treatment. On this basis, this study will further verify the efficacy of preoperative neoadjuvant chemotherapy in patients with resectable locally advanced head and neck squamous cell carcinoma with PD-L1 inhibitors combined with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Nab paclitaxel, Drug: Carboplatin, Drug: adelbelimumabAll patients received nab-paclitaxel 260 mg/m2, carboplatin AUC=5 and adelbelimumab 1200 mg intravenously on day 1 of each 3-week cycle for 3 cycles. All patients were given conventional drugs to prevent vomiting in each cycle, and intravenous dexamethasone was given to prevent allergy before each dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18-75 years old
- According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVB tumors of non-oropharyngeal cancers confirmed by pathology as head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx) and HPV-negative oropharyngeal cancer patients, or HPV-positive oropharyngeal cancer patients with stage II-III tumors
- Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis
- According to RECIST 1.1, there is at least one measurable tumor lesion
- The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1
Key exclusion criteria (4 listed)
- The patient has abnormal blood indicators, abnormal liver and kidney function, and cannot tolerate the clinical research process after multidisciplinary consultation evaluation
- The patient has previously suffered from other tumors, or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy
- The entire clinical research process cannot be completed due to personal, social and economic reasons
- Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs -
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 |
|---|---|---|
| Nab paclitaxelAll patients received nab-paclitaxel 260 mg/m2 intravenously on day 1 of each 3-week cycle for 3 cycles. | Drug | intervention group |
| CarboplatinAll patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles. | Drug | intervention group |
| adelbelimumabAll patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles. | Drug | intervention group |
Primary outcome
Postoperative pathological complete response rate
Time frame: one week after operative
The postoperative specimens were sent to the pathology department for fixation, sectioning, and observation. Two pathologists judge whether the subject's tumor remains. If there is a disagreement between the two, the third senior pathologist will discuss and decide
2 secondary outcomes
Major pathological response rate
Time frame: one week after operative
Two years overall Survival
Time frame: Two years after investigator enrollment
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 29 Aug 2023.
- Background: PubMed 30219915Colevas AD, Bahleda R, Braiteh F, Balmanoukian A, Brana I, Chau NG, Sarkar I, Molinero L, Grossman W, Kabbinavar F, Fasso M, O'Hear C, Powderly J. Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. Ann Oncol. 2018 Nov 1;29(11):2247-2253. doi: 10.1093/annonc/mdy411.
- Background: PubMed 35576956Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.
- Background: PubMed 25428504Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.
- Background: PubMed 33580222Doroshow DB, Bhalla S, Beasley MB, Sholl LM, Kerr KM, Gnjatic S, Wistuba II, Rimm DL, Tsao MS, Hirsch FR. PD-L1 as a biomarker of response to immune-checkpoint inhibitors. Nat Rev Clin Oncol. 2021 Jun;18(6):345-362. doi: 10.1038/s41571-021-00473-5. Epub 2021 Feb 12.
- Background: PubMed 31507611Wu Y, Chen W, Xu ZP, Gu W. PD-L1 Distribution and Perspective for Cancer Immunotherapy-Blockade, Knockdown, or Inhibition. Front Immunol. 2019 Aug 27;10:2022. doi: 10.3389/fimmu.2019.02022. eCollection 2019.
- Background: PubMed 35766967Zhang Z, Wu B, Peng G, Xiao G, Huang J, Ding Q, Yang C, Xiong X, Ma H, Shi L, Yang J, Hong X, Wei J, Qin Y, Wan C, Zhong Y, Zhou Y, Zhao X, Leng Y, Zhang T, Wu G, Yao M, Zhang X, Yang K. Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial. Clin Cancer Res. 2022 Aug 2;28(15):3268-3276. doi: 10.1158/1078-0432.CCR-22-0666.
- Background: PubMed 31679945Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.
- Background: PubMed 29644214Seidel JA, Otsuka A, Kabashima K. Anti-PD-1 and Anti-CTLA-4 Therapies in Cancer: Mechanisms of Action, Efficacy, and Limitations. Front Oncol. 2018 Mar 28;8:86. doi: 10.3389/fonc.2018.00086. eCollection 2018.
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- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab paclitaxel, Carboplatin and adelbelimumab in people with Head and Neck Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site 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 11 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Zhiquan Huang (13826142898, hzhquan@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pathological complete response rate (time frame: one week after operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06016413, which also lists 14 linked publications.
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 29 Aug 2023.