Resectable Head and Neck Squamous Cell CarcinomaPhase 2NCT07492914
Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Sacituzumab Govitecan and Tagitanlimab in people with Resectable Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the anti-tumor activity, safety and tolerability of the combination of Sacituzumab govitecan and Tagitanlimab as neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Sacituzumab Govitecan and Tagitanlimab
- 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
- 11 May 2026to 31 Mar 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and above, of any gender.
- Histopathologically confirmed resectable head and neck squamous cell carcinoma (HNSCC), excluding nasopharyngeal, salivary gland, and thyroid malignant tumors; surgically assessed as resectable or potentially resectable.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Sufficient organ and bone marrow function, meeting the following: absolute neutrophil count (NEUT) ≥1.5×10⁹/L, platelet count (PLT) ≥80×10⁹/L, hemoglobin ≥8 g/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) >60 mL/min; international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Voluntarily participate in the study, sign the informed consent form, and be able to comply with scheduled study visits and relevant procedures in the protocol.
Who cannot join
- A history of other malignant tumors within the past 5 years, except for cured and non-recurrent malignancies (e.g., basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ).
- Active autoimmune disease or relevant medical history (except for type 1 diabetes mellitus under stable insulin therapy), including but not limited to immune neurological diseases, systemic lupus erythematosus, inflammatory bowel disease, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome.
- A history of allergic diseases or severe drug allergy (anaphylaxis requiring hospitalization); known hypersensitivity to anti-PD-L1 antibodies, TROP2 antibody-drug conjugates (ADCs), or excipients of the study drugs.
- Prior anti-tumor treatment involving anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, TROP2 ADCs, or anti-tumor vaccine therapy.
- Receipt of a live infectious vaccine within 4 weeks prior to the first dose or planned vaccination during the study period; major surgery or severe trauma within 4 weeks prior to the first dose.
- Systemic use of corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressants within 14 days prior to the first dose (inhaled or topical steroids and adrenal replacement therapy are permitted).
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- Severe medical conditions, including New York Heart Association (NYHA) class II or higher heart failure, ischemic heart disease, clinically significant arrhythmias requiring intervention, left ventricular ejection fraction (LVEF) <50% on echocardiography, or prolonged QTc interval (males >450 msec, females >470 msec).
- A known history of interstitial lung disease or high clinical suspicion of interstitial lung disease; active pulmonary tuberculosis or uncontrolled previous tuberculosis infection.
- Hyperthyroidism or organic thyroid disease (patients with hypothyroidism under stable thyroid hormone replacement therapy are eligible for enrollment).
- Active infection, unexplained fever within 48 hours prior to the first dose, or systemic antibiotic use within 1 week prior to signing the informed consent form.
- Active hepatitis B (HBV DNA ≥2000 IU/ml or ≥10⁴ copies/ml), active hepatitis C (positive anti-HCV and HCV RNA above the lower limit of detection), positive HIV antibody, or a history of acquired immunodeficiency syndrome (AIDS).
- A definite history of neurological or psychiatric diseases such as epilepsy or dementia.
- A history of drug or alcohol abuse.
- Pregnant or lactating females; patients (or their partners) planning pregnancy, having unprotected sexual intercourse, or refusing to take effective contraceptive measures during the study and for 3 months after study completion.
- Receipt of other investigational drugs within 4 weeks prior to the first dose, or concurrent participation in other interventional clinical studies (observational or follow-up interventional studies are excluded).
- Other circumstances deemed unsuitable for study participation by the investigator.
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, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Hong-Shuai Li, +86-18384262516, lihongshuai456@163.com
Xing-Chen Peng, pxx2014@163.com
About this study
Official title: A Single-Arm, Phase II Prospective Study Of Lucanoximab Combined With Tagolimab As Neoadjuvant Therapy For Resectable Head And Neck Squamous Cell Carcinoma
The goal of this clinical trial is to evaluate the anti-tumor activity, safety and tolerability of the combination of Sacituzumab govitecan and Tagitanlimab as neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma (HNSCC). It will also explore potential biomarkers related to the efficacy of this combined therapy. The main questions it aims to answer are:
Does the combination of Sacituzumab govitecan and Tagitanlimab improve the major pathological response rate (MPR) in patients with resectable HNSCC?
Read more
What adverse reactions (side effects) do participants experience when receiving this combined neoadjuvant therapy?
Does this combined therapy improve participants' objective response rate (ORR), survival time and quality of life?
This is a single-arm, open-label, prospective Phase II clinical study conducted at West China Hospital of Sichuan University. A total of 30 eligible patients will be enrolled, and no placebo control will be used. The study will evaluate the efficacy and safety of the combined therapy by monitoring clinical indicators, pathological results and adverse events throughout the trial.
Participants will:
Receive Sacituzumab govitecan (5mg/kg) and Tagitanlimab (900mg) intravenously every 2 weeks, for a total of 2 treatment cycles.
Patients will undergo surgical resection 3-6 weeks after completion of neoadjuvant therapy. Adjuvant therapy (concurrent chemoradiotherapy or radiotherapy alone) will be administered according to pathological risk factors, together with 15 cycles of Tagitanlimab as adjuvant immunotherapy.
Visit the clinic regularly for physical examinations, laboratory tests (such as blood routine, liver and kidney function), imaging examinations (such as head and neck MRI/CT) and safety checkups according to the study schedule.
Provide biological samples (peripheral blood, tumor tissue, saliva, feces) at specified time points for biomarker detection.
Complete quality-of-life questionnaires (such as EORTC QLQ-C30) regularly to assess changes in daily functioning.
Note: Participants will not be charged for the study drugs (Sacituzumab govitecan and Tagitanlimab ), and will receive appropriate subsidies for study-related visits and blood collection. The research team will provide active treatment and corresponding compensation if participants experience study-related adverse reactions.
- Being tested
- Sacituzumab Govitecan, Tagitanlimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab GovitecanDrug
Humanized anti-TROP2 antibody-drug conjugate (ADC) linked to a topoisomerase I inhibitor via a stable linker, featuring high tumor targeting and efficient cytotoxic drug release. Administered intravenously at 5mg/kg every 2 weeks for 2 cycles (90±15 minutes infusion per dose) as neoadjuvant therapy for resectable head and neck squamous cell carcinoma (HNSCC), delivering targeted cytotoxic effects to TROP2-overexpressing tumor cells to inhibit tumor growth.
TagitanlimabDrug
Humanized IgG1κ anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 signaling pathway to restore T cell-mediated anti-tumor immunity and reverse tumor immune escape. Administered intravenously at a fixed 900mg dose every 2 weeks for 2 cycles (120 minutes infusion per dose) as neoadjuvant therapy for resectable head and neck squamous cell carcinoma (HNSCC), used in combination with Sacituzumab Govitecan to achieve synergistic anti-tumor activity.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab govitecan + Tagitanlimab Neoadjuvant Therapy | Experimental | Eligible patients with resectable head and neck squamous cell carcinoma (HNSCC) will receive neoadjuvant combination therapy of Sacituzumab govitecan and Tagitanlimab for 2 sequential 2-week treatment cycles. Sacituzumab govitecan is administered intravenously at a dose of 5mg/kg every 2 weeks, and Tagitanlimab is administered intravenously at a fixed dose of 900mg every 2 weeks, with both agents delivered in the same cycles. Within 3-6 weeks after the completion of neoadjuvant therapy, patients will undergo surgical resection of the primary HNSCC tumor and regional lymph nodes. Postoperative adjuvant therapy will commence 4-6 weeks post-surgery. Patients with pathological high-risk factors (e.g., positive surgical margins, extranodal extension) will receive concurrent chemoradiotherapy plus 15 cycles of taglixlimab adjuvant immunotherapy, while patients with general risk factors (e.g., pT3/pT4, pN2/pN3) will be treated with radiotherapy combined with the same 15-cycle Tagitanlimab. Receives: Drug: Sacituzumab Govitecan; Drug: Tagitanlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate (MPR)
Major Pathological Response Rate (MPR) is defined as the proportion of enrolled patients with residual viable tumor (RVT) ≤10% in the primary tumor and regional lymph node resection specimens after completion of 2 cycles of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab therapy, assessed per immune-related pathological response criteria (irPRC) by independent pathological reviewers. MPR is the primary efficacy endpoint to evaluate the anti-tumor activity of the combined neoadjuvant regimen in resectable head and neck squamous cell carcinoma (HNSCC).
Measured: Assessed at the time of surgical resection (3 to 6 weeks after the completion of neoadjuvant therapy)
Secondary outcomes (5)
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of enrolled patients achieving a confirmed complete response (CR) or partial response (PR) in tumor lesions after 2 cycles of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab therapy, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent radiological reviewers. ORR reflects the short-term anti-tumor efficacy of the combined neoadjuvant regimen on measurable HNSCC lesions.
Measured: Assessed at 3 to 6 weeks after the completion of neoadjuvant therapy (prior to surgical resection)
Event-Free Survival (EFS)
Event-Free Survival (EFS) is defined as the time from the first administration of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab to the first occurrence of any study event, including radiologically or pathologically confirmed disease progression, local/distant tumor recurrence, or all-cause mortality. EFS evaluates the medium-term disease control efficacy of the combined regimen in resectable HNSCC patients.
Measured: Assessed up to 2 years after the first dose of neoadjuvant therapy (with regular follow-up every 3-4 months)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first administration of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab to all-cause mortality in enrolled patients. OS is a key endpoint reflecting the long-term survival benefit of the combined neoadjuvant regimen for resectable HNSCC patients, with survival status monitored through regular clinical follow-up.
Measured: Assessed up to 5 years after the first dose of neoadjuvant therapy (follow-up every 6 months for years 3-5, annually after year 5)
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Incidence and severity of Treatment-Related Adverse Events (TRAEs) are defined as all adverse medical events judged to be related to Sacituzumab Govitecan and/or Tagitanlimab during the entire study period, graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. This endpoint evaluates the safety and tolerability of the combined neoadjuvant regimen in resectable HNSCC patients.
Measured: Assessed from the first dose of neoadjuvant therapy to 90 days after the last study drug administration (with 30-day post-treatment safety follow-up)
Health-Related Quality of Life (HRQoL) Assessed by EORTC QLQ-C30
Health-related quality of life (HRQoL) was assessed via the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), which measures physical, emotional, social and cognitive function, as well as cancer-related symptom burden in malignant tumor patients. HRQoL scores at baseline and post-treatment were compared to quantify the combined neoadjuvant regimen's impact on patients' daily function and overall well-being.
Scale Specifications: All EORTC QLQ-C30 subscales (functional/symptom) and the global health status/QoL scale are scored 0-100. Higher scores reflect better functional status/global health, while higher scores on symptom scales indicate more severe symptom burden.
Measured: Assessed at baseline (prior to the initiation of neoadjuvant therapy), post-neoadjuvant therapy (3-6 weeks after the completion of neoadjuvant treatment), and at 6 and 12 months following surgical resection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start11 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492914
- Sponsor's protocol ID
- 2025-2634
- Status last verified
- May 2026
- First submitted
- 19 Mar 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase II Prospective Study Of Lucanoximab Combined With Tagolimab As Neoadjuvant Therapy For Resectable Head And Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07492914
- Acronym / sponsor ID
- 2025-2634
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 11 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 25 Mar 2026 (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.
The goal of this clinical trial is to evaluate the anti-tumor activity, safety and tolerability of the combination of Sacituzumab govitecan and Tagitanlimab as neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma (HNSCC). It will also explore potential biomarkers related to the efficacy of this combined therapy. The main questions it aims to answer are:
Does the combination of Sacituzumab govitecan and Tagitanlimab improve the major pathological response rate (MPR) in patients with resectable HNSCC?
What adverse reactions (side effects) do participants experience when receiving this combined neoadjuvant therapy?
Does this combined therapy improve participants' objective response rate (ORR), survival time and quality of life?
This is a single-arm, open-label, prospective Phase II clinical study conducted at West China Hospital of Sichuan University. A total of 30 eligible patients will be enrolled, and no placebo control will be used. The study will evaluate the efficacy and safety of the combined therapy by monitoring clinical indicators, pathological results and adverse events throughout the trial.
Participants will:
Receive Sacituzumab govitecan (5mg/kg) and Tagitanlimab (900mg) intravenously every 2 weeks, for a total of 2 treatment cycles.
Patients will undergo surgical resection 3-6 weeks after completion of neoadjuvant therapy. Adjuvant therapy (concurrent chemoradiotherapy or radiotherapy alone) will be administered according to pathological risk factors, together with 15 cycles of Tagitanlimab as adjuvant immunotherapy.
Visit the clinic regularly for physical examinations, laboratory tests (such as blood routine, liver and kidney function), imaging examinations (such as head and neck MRI/CT) and safety checkups according to the study schedule.
Provide biological samples (peripheral blood, tumor tissue, saliva, feces) at specified time points for biomarker detection.
Complete quality-of-life questionnaires (such as EORTC QLQ-C30) regularly to assess changes in daily functioning.
Note: Participants will not be charged for the study drugs (Sacituzumab govitecan and Tagitanlimab ), and will receive appropriate subsidies for study-related visits and blood collection. The research team will provide active treatment and corresponding compensation if participants experience study-related adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab govitecan + Tagitanlimab Neoadjuvant Therapy | Experimental | Drug: Sacituzumab Govitecan, Drug: TagitanlimabEligible patients with resectable head and neck squamous cell carcinoma (HNSCC) will receive neoadjuvant combination therapy of Sacituzumab govitecan and Tagitanlimab for 2 sequential 2-week treatment cycles. Sacituzumab govitecan is administered intravenously at a dose of 5mg/kg every 2 weeks, and Tagitanlimab is administered intravenously at a fixed dose of 900mg every 2 weeks, with both agents delivered in the same cycles. Within 3-6 weeks after the completion of neoadjuvant therapy, patients will undergo surgical resection of the primary HNSCC tumor and regional lymph nodes. Postoperative adjuvant therapy will commence 4-6 weeks post-surgery. Patients with pathological high-risk factors (e.g., positive surgical margins, extranodal extension) will receive concurrent chemoradiotherapy plus 15 cycles of taglixlimab adjuvant immunotherapy, while patients with general risk factors (e.g., pT3/pT4, pN2/pN3) will be treated with radiotherapy combined with the same 15-cycle Tagitanlimab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years and above, of any gender.
- Histopathologically confirmed resectable head and neck squamous cell carcinoma (HNSCC), excluding nasopharyngeal, salivary gland, and thyroid malignant tumors; surgically assessed as resectable or potentially resectable.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Sufficient organ and bone marrow function, meeting the following: absolute neutrophil count (NEUT) ≥1.5×10⁹/L, platelet count (PLT) ≥80×10⁹/L, hemoglobin ≥8 g/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) >60 mL/min; international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Voluntarily participate in the study, sign the informed consent form, and be able to comply with scheduled study visits and relevant procedures in the protocol.
Key exclusion criteria (16 listed)
- A history of other malignant tumors within the past 5 years, except for cured and non-recurrent malignancies (e.g., basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ).
- Active autoimmune disease or relevant medical history (except for type 1 diabetes mellitus under stable insulin therapy), including but not limited to immune neurological diseases, systemic lupus erythematosus, inflammatory bowel disease, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome.
- A history of allergic diseases or severe drug allergy (anaphylaxis requiring hospitalization); known hypersensitivity to anti-PD-L1 antibodies, TROP2 antibody-drug conjugates (ADCs), or excipients of the study drugs.
- Prior anti-tumor treatment involving anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, TROP2 ADCs, or anti-tumor vaccine therapy.
- Receipt of a live infectious vaccine within 4 weeks prior to the first dose or planned vaccination during the study period; major surgery or severe trauma within 4 weeks prior to the first dose.
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 |
|---|---|---|
| Sacituzumab GovitecanHumanized anti-TROP2 antibody-drug conjugate (ADC) linked to a topoisomerase I inhibitor via a stable linker, featuring high tumor targeting and efficient cytotoxic drug release. Administered intravenously at 5mg/kg every 2 weeks for 2 cycles (90±15 minutes infusion per dose) as neoadjuvant therapy for resectable head and neck squamous cell carcinoma (HNSCC), delivering targeted cytotoxic effects to TROP2-overexpressing tumor cells to inhibit tumor growth. | Drug | Sacituzumab govitecan + Tagitanlimab Neoadjuvant Therapy |
| TagitanlimabHumanized IgG1κ anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 signaling pathway to restore T cell-mediated anti-tumor immunity and reverse tumor immune escape. Administered intravenously at a fixed 900mg dose every 2 weeks for 2 cycles (120 minutes infusion per dose) as neoadjuvant therapy for resectable head and neck squamous cell carcinoma (HNSCC), used in combination with Sacituzumab Govitecan to achieve synergistic anti-tumor activity. | Drug | Sacituzumab govitecan + Tagitanlimab Neoadjuvant Therapy |
Primary outcome
Major Pathological Response Rate (MPR)
Time frame: Assessed at the time of surgical resection (3 to 6 weeks after the completion of neoadjuvant therapy)
Major Pathological Response Rate (MPR) is defined as the proportion of enrolled patients with residual viable tumor (RVT) ≤10% in the primary tumor and regional lymph node resection specimens after completion of 2 cycles of neoadjuvant Sacituzumab Govitecan plus Tagitanlimab therapy, assessed per immune-related pathological response criteria (irPRC) by independent pathological reviewers. MPR is the primary efficacy endpoint to evaluate the anti-tumor activity of the combined neoadjuvant regimen in resectable head and neck squamous cell carcinoma (HNSCC).
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Assessed at 3 to 6 weeks after the completion of neoadjuvant therapy (prior to surgical resection)
Event-Free Survival (EFS)
Time frame: Assessed up to 2 years after the first dose of neoadjuvant therapy (with regular follow-up every 3-4 months)
Overall Survival (OS)
Time frame: Assessed up to 5 years after the first dose of neoadjuvant therapy (follow-up every 6 months for years 3-5, annually after year 5)
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Time frame: Assessed from the first dose of neoadjuvant therapy to 90 days after the last study drug administration (with 30-day post-treatment safety follow-up)
Health-Related Quality of Life (HRQoL) Assessed by EORTC QLQ-C30
Time frame: Assessed at baseline (prior to the initiation of neoadjuvant therapy), post-neoadjuvant therapy (3-6 weeks after the completion of neoadjuvant treatment), and at 6 and 12 months following surgical resection.
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 13 May 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.
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 Sacituzumab Govitecan and Tagitanlimab in people with Resectable Head and Neck Squamous Cell Carcinoma, run by West China Hospital 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 5 inclusion and 16 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 13 May 2026. 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 Hong-Shuai Li, Dr (+86-18384262516, lihongshuai456@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response Rate (MPR) (time frame: Assessed at the time of surgical resection (3 to 6 weeks after the completion of neoadjuvant therapy)). 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 13 May 2026.