Head and Neck Squamous Cell Carcinoma HNSCCPhase 1NCT07457281
GV20-0251 and Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm Study
A Phase 1 study testing GV20-0251 and Sintilimab in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by West China Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether neoadjuvant GV20-0251 combined with sintilimab is safe and tolerable, and to explore its preliminary antitumor activity, in adults with resectable, locally advanced head and neck squamous cell carcinoma at West China Hospital, Sichuan University. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- GV20-0251 and Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Jun 2028
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years, inclusive, at the time of signing informed consent; male or female;
- Histologically confirmed head and neck squamous cell carcinoma (HNSCC) meeting all of the following conditions:
- 1). Newly diagnosed, locally advanced HNSCC without distant metastasis (excluding nasopharyngeal, salivary gland, and thyroid malignancies): Non-oropharyngeal HNSCC and HPV-negative oropharyngeal cancer: Stage III, IVA, or IVB;HPV-positive oropharyngeal cancer: Stage II or III；HPV status for oropharyngeal cancer will be determined by p16 immunohistochemistry; 2). Assessed by the head and neck surgeon as resectable and amenable to surgical treatment; 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4.Adequate organ and bone marrow function, defined as follows:
- Hematologic function:Absolute neutrophil count (ANC) ≥1.5 × 10^9/L;Platelet count (PLT) ≥80 × 10^9/L;Hemoglobin ≥8 g/dL.
- Hepatic function:Aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN);Alanine aminotransferase (ALT) ≤2.5 × ULN;Total bilirubin (TBIL) ≤1.5 × ULN;
- Serum albumin ≥2.8 g/dL;
- Renal function:Serum creatinine ≤1.5 × ULN, orCreatinine clearance (CrCl) >60 mL/min;
- Coagulation function:International normalized ratio (INR) ≤1.5;Activated partial thromboplastin time (APTT) ≤1.5 × ULN; 5.Participants must voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with protocol-required visits and study procedures.
Who cannot join
- History of other malignancies, except for malignancies considered eligible by the investigator, such as adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or intramucosal gastrointestinal carcinoma that has been cured and has not recurred within 5 years;
- Active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurologic disorders, multiple sclerosis, autoimmune demyelinating neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome; participants with type 1 diabetes mellitus controlled with a stable dose of insulin may be enrolled;
- Allergic disease, severe drug allergy history, or known hypersensitivity to macromolecular protein preparations or any component of PD-1 monoclonal antibody injection; severe hypersensitivity is defined as Grade 3 or higher according to CTCAE;
- Prior receipt of any of the following treatments: 1) prior treatment with PD-1 antibody, PD-L1 antibody, CTLA-4 antibody, EGFR antibody, or EGFR tyrosine kinase inhibitor; 2) prior receipt of any antitumor vaccine; 3) receipt of any live vaccine for prevention of infectious disease within 4 weeks before first dose or planned use during the study, such as influenza vaccine or varicella vaccine; 4) major surgery or severe trauma within 4 weeks before first dose;
- Requirement for systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days before study drug administration; inhaled or topical corticosteroids and physiologic replacement doses of adrenal steroids are permitted;
- Severe medical disease, including New York Heart Association (NYHA) Class II or higher cardiac dysfunction, ischemic heart disease such as myocardial infarction or angina pectoris, clinically significant supraventricular or ventricular arrhythmias, left ventricular ejection fraction <50% by echocardiography, QTc interval >450 msec in men or >470 msec in women, or any electrocardiographic abnormality considered by the investigator to pose additional risk with the study drug;
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- Known history of interstitial lung disease, noninfectious pneumonitis, or high suspicion of interstitial lung disease, or any condition that may interfere with the detection or management of suspected drug-related pulmonary toxicity; participants with a prior history of drug-induced or radiation-induced noninfectious pneumonitis who are currently asymptomatic may be enrolled; active tuberculosis, or previous tuberculosis infection that remains uncontrolled after treatment;
- Hyperthyroidism or organic thyroid disease; participants with hypothyroidism controlled with thyroid hormone replacement therapy may be enrolled if considered adequately controlled by the investigator and/or endocrinologist;
- Active infection, unexplained fever during screening or within 48 hours before first dose, or use of systemic antibiotics within 1 week before signing informed consent;
- Active hepatitis B infection (HBV DNA ≥2000 IU/mL or 10^4 copies/mL), active hepatitis C infection (positive HCV antibody with HCV RNA above the lower limit of detection of the assay), known positive history of human immunodeficiency virus (HIV) infection, or known acquired immunodeficiency syndrome (AIDS);
- Definite history of neurologic or psychiatric disorders, such as epilepsy or dementia;
- Known history of drug abuse or alcohol abuse within 3 months before enrollment;
- Pregnancy or lactation; intention to conceive during treatment or within 4 months after the last dose in the participant or the participant's partner, unprotected sexual activity without contraception, or unwillingness to use adequate contraceptive measures such as condoms, intrauterine devices, or partner sterilization;
- Receipt of any investigational drug within 4 weeks before first use of study drug, or concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study;
- Any other condition that, in the opinion of the investigator, may interfere with study participation, completion of study treatment, or follow-up.
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, Sichuan University
Chengdu
Huaju Yang, +8613340239461, yhjyanghuaju@163.com
About this study
Official title: GV20-0251 Combined With Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Study
The goal of this clinical trial is to learn whether neoadjuvant GV20-0251 combined with sintilimab is safe and tolerable, and to explore its preliminary antitumor activity, in adults with resectable, locally advanced head and neck squamous cell carcinoma at West China Hospital, Sichuan University. The main questions it aims to answer are: What is the incidence of dose-limiting toxicities (DLTs) during neoadjuvant treatment with GV20-0251 in combination with sintilimab in the dose-escalation phase? What is the major pathologic response (MPR) rate in resected specimens after neoadjuvant treatment? Participants will receive two 3-week cycles of neoadjuvant therapy using a 3+3 dose-escalation design (GV20-0251 at 10 mg/kg or 20 mg/kg plus fixed-dose sintilimab 200 mg, both given by intravenous infusion on Day 1 of each cycle), undergo protocol-specified safety monitoring with adverse events graded per CTCAE v5.0 and routine clinical assessments and laboratory tests, proceed to definitive surgery after neoadjuvant therapy, receive postoperative adjuvant therapy, and complete post-treatment safety follow-up and protocol-defined long-term follow-up for disease status and survival outcomes.
- Being tested
- GV20-0251, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV20-0251Drug
GV20-0251 administered by intravenous infusion on a protocol-specified schedule as part of neoadjuvant treatment prior to surgery.
SintilimabDrug
Sintilimab (PD-1 inhibitor) administered as neoadjuvant therapy in combination with GV20-0251 prior to planned surgery, according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| GV20-0251 (Dose Level 1) + Sintilimab | Experimental | Neoadjuvant treatment: Participants receive GV20-0251 10 mg/kg plus sintilimab by intravenous (IV) infusion on Day 1 of each 21-day cycle for 2 cycles prior to surgery.
Adjuvant treatment: Following surgical resection, participants receive sintilimab by IV infusion on Day 1 of each 21-day cycle for 15 cycles, plus investigator's choice of standard-of-care (SOC) treatment consisting of radiotherapy, with or without cisplatin 100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 3 cycles (up to 9 weeks). Receives: Drug: GV20-0251; Drug: Sintilimab |
| GV20-0251 (Dose Level 2) + Sintilimab | Experimental | Neoadjuvant treatment: Participants receive GV20-0251 20 mg/kg plus sintilimab by intravenous (IV) infusion on Day 1 of each 21-day cycle for 2 cycles prior to surgery.
Adjuvant treatment: Following surgical resection, participants receive sintilimab by IV infusion on Day 1 of each 21-day cycle for 15 cycles, plus investigator's choice of standard-of-care (SOC) treatment consisting of radiotherapy, with or without cisplatin 100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 3 cycles (up to 9 weeks). Receives: Drug: GV20-0251; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) of GV20-0251 in combination with sintilimab
The incidence of dose-limiting toxicities (DLTs) of GV20-0251 in combination with sintilimab will be assessed to determine the recommended expansion dose (RDE).
Measured: From first dose through the end of the DLT assessment window (21 days)
Secondary outcomes (5)
Pathologic Complete Response (pCR) Rate
Among participants who undergo surgery, pathologic complete response (pCR) is defined according to immune-related pathologic response criteria (irPR) as no residual viable tumor cells in the tumor bed or resected lymph nodes (%RVT = 0).
Measured: At the time of surgery, after completion of neoadjuvant treatment
Major Pathologic Response (MPR) Rate
Among participants who undergo surgery, major pathologic response (MPR) is defined according to immune-related pathologic response criteria (irPRC) as ≤10% residual viable tumor cells in the tumor bed (%RVT ≤10%), regardless of whether residual viable tumor cells are present in lymph nodes.
Measured: At the time of surgery, after completion of neoadjuvant treatment
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR), as assessed according to RECIST version 1.1 and iRECIST.
Measured: From baseline to pre-operative tumor assessment following 2 cycles of neoadjuvant therapy (up to 9 weeks).
Adverse Events (AEs)
Adverse events (AEs) will be assessed according to CTCAE version 5.0, and all treatment-related adverse events will be reported to evaluate the safety of treatment.
Measured: From first dose through 30 days after the last dose of neoadjuvant treatment
Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the time from first dose to the first occurrence of any of the following events: disease progression during neoadjuvant treatment that precludes definitive surgery, local, regional, or distant recurrence after surgery, or death from any cause. Participants without an event will be censored at the date of last disease assessment or last follow-up.
Measured: From first dose to the first occurrence of an event, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma HNSCCStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 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
- Investigators
- Xingchen Peng, MD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457281
- Sponsor's protocol ID
- 2025-2551
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 25 Mar 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GV20-0251 Combined With Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07457281
- Acronym / sponsor ID
- 2025-2551
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 9 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 learn whether neoadjuvant GV20-0251 combined with sintilimab is safe and tolerable, and to explore its preliminary antitumor activity, in adults with resectable, locally advanced head and neck squamous cell carcinoma at West China Hospital, Sichuan University. The main questions it aims to answer are: What is the incidence of dose-limiting toxicities (DLTs) during neoadjuvant treatment with GV20-0251 in combination with sintilimab in the dose-escalation phase? What is the major pathologic response (MPR) rate in resected specimens after neoadjuvant treatment? Participants will receive two 3-week cycles of neoadjuvant therapy using a 3+3 dose-escalation design (GV20-0251 at 10 mg/kg or 20 mg/kg plus fixed-dose sintilimab 200 mg, both given by intravenous infusion on Day 1 of each cycle), undergo protocol-specified safety monitoring with adverse events graded per CTCAE v5.0 and routine clinical assessments and laboratory tests, proceed to definitive surgery after neoadjuvant therapy, receive postoperative adjuvant therapy, and complete post-treatment safety follow-up and protocol-defined long-term follow-up for disease status and survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GV20-0251 (Dose Level 1) + Sintilimab | Experimental | Drug: GV20-0251, Drug: SintilimabNeoadjuvant treatment: Participants receive GV20-0251 10 mg/kg plus sintilimab by intravenous (IV) infusion on Day 1 of each 21-day cycle for 2 cycles prior to surgery. Adjuvant treatment: Following surgical resection, participants receive sintilimab by IV infusion on Day 1 of each 21-day cycle for 15 cycles, plus investigator's choice of standard-of-care (SOC) treatment consisting of radiotherapy, with or without cisplatin 100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 3 cycles (up to 9 weeks). |
| GV20-0251 (Dose Level 2) + Sintilimab | Experimental | Drug: GV20-0251, Drug: SintilimabNeoadjuvant treatment: Participants receive GV20-0251 20 mg/kg plus sintilimab by intravenous (IV) infusion on Day 1 of each 21-day cycle for 2 cycles prior to surgery. Adjuvant treatment: Following surgical resection, participants receive sintilimab by IV infusion on Day 1 of each 21-day cycle for 15 cycles, plus investigator's choice of standard-of-care (SOC) treatment consisting of radiotherapy, with or without cisplatin 100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 3 cycles (up to 9 weeks). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 70 years, inclusive, at the time of signing informed consent; male or female;
- Histologically confirmed head and neck squamous cell carcinoma (HNSCC) meeting all of the following conditions:
- 1). Newly diagnosed, locally advanced HNSCC without distant metastasis (excluding nasopharyngeal, salivary gland, and thyroid malignancies): Non-oropharyngeal HNSCC and HPV-negative oropharyngeal cancer: Stage III, IVA, or IVB;HPV-positive oropharyngeal cancer: Stage II or III；HPV status for oropharyngeal cancer will be determined by p16 immunohistochemistry; 2). Assessed by the head and neck surgeon as resectable and amenable to surgical treatment; 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4.Adequate organ and bone marrow function, defined as follows:
- Hematologic function:Absolute neutrophil count (ANC) ≥1.5 × 10^9/L;Platelet count (PLT) ≥80 × 10^9/L;Hemoglobin ≥8 g/dL.
- Hepatic function:Aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN);Alanine aminotransferase (ALT) ≤2.5 × ULN;Total bilirubin (TBIL) ≤1.5 × ULN;
Key exclusion criteria (15 listed)
- History of other malignancies, except for malignancies considered eligible by the investigator, such as adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or intramucosal gastrointestinal carcinoma that has been cured and has not recurred within 5 years;
- Active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurologic disorders, multiple sclerosis, autoimmune demyelinating neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome; participants with type 1 diabetes mellitus controlled with a stable dose of insulin may be enrolled;
- Allergic disease, severe drug allergy history, or known hypersensitivity to macromolecular protein preparations or any component of PD-1 monoclonal antibody injection; severe hypersensitivity is defined as Grade 3 or higher according to CTCAE;
- Prior receipt of any of the following treatments: 1) prior treatment with PD-1 antibody, PD-L1 antibody, CTLA-4 antibody, EGFR antibody, or EGFR tyrosine kinase inhibitor; 2) prior receipt of any antitumor vaccine; 3) receipt of any live vaccine for prevention of infectious disease within 4 weeks before first dose or planned use during the study, such as influenza vaccine or varicella vaccine; 4) major surgery or severe trauma within 4 weeks before first dose;
- Requirement for systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days before study drug administration; inhaled or topical corticosteroids and physiologic replacement doses of adrenal steroids are permitted;
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 |
|---|---|---|
| GV20-0251GV20-0251 administered by intravenous infusion on a protocol-specified schedule as part of neoadjuvant treatment prior to surgery. | Drug | GV20-0251 (Dose Level 1) + Sintilimab, GV20-0251 (Dose Level 2) + Sintilimab |
| SintilimabSintilimab (PD-1 inhibitor) administered as neoadjuvant therapy in combination with GV20-0251 prior to planned surgery, according to the study protocol. | Drug | GV20-0251 (Dose Level 1) + Sintilimab, GV20-0251 (Dose Level 2) + Sintilimab |
Primary outcome
Incidence of dose-limiting toxicities (DLTs) of GV20-0251 in combination with sintilimab
Time frame: From first dose through the end of the DLT assessment window (21 days)
The incidence of dose-limiting toxicities (DLTs) of GV20-0251 in combination with sintilimab will be assessed to determine the recommended expansion dose (RDE).
5 secondary outcomes
Pathologic Complete Response (pCR) Rate
Time frame: At the time of surgery, after completion of neoadjuvant treatment
Major Pathologic Response (MPR) Rate
Time frame: At the time of surgery, after completion of neoadjuvant treatment
Objective Response Rate (ORR)
Time frame: From baseline to pre-operative tumor assessment following 2 cycles of neoadjuvant therapy (up to 9 weeks).
Adverse Events (AEs)
Time frame: From first dose through 30 days after the last dose of neoadjuvant treatment
Event-Free Survival (EFS)
Time frame: From first dose to the first occurrence of an event, assessed up to 2 years
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 25 Mar 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.
Xingchen Peng, MD principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GV20-0251 and Sintilimab in people with Head and Neck Squamous Cell Carcinoma HNSCC, 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 8 inclusion and 15 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 25 Mar 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Huaju yang (+8613340239461, yhjyanghuaju@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) of GV20-0251 in combination with sintilimab (time frame: From first dose through the end of the DLT assessment window (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 25 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.