Actively Recruiting
GV20-0251 and Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm Study
Led by West China Hospital · Updated on 2026-03-25
9
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GV20-0251 and Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years at the time of informed consent
- Male or female
- Histologically confirmed head and neck squamous cell carcinoma (HNSCC) newly diagnosed, locally advanced without distant metastasis
- Non-oropharyngeal HNSCC and HPV-negative oropharyngeal cancer at Stage III, IVA, or IVB; HPV-positive oropharyngeal cancer at Stage II or III
- HPV status determined by p16 immunohistochemistry for oropharyngeal cancer
- Cancer assessed as resectable and suitable for surgery by a head and neck surgeon
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function, including ANC ≥1.5 x 10^9/L, platelet count ≥80 x 10^9/L, hemoglobin ≥8 g/dL
- Liver function with AST and ALT ≤2.5 times upper limit of normal, total bilirubin ≤1.5 times upper limit
- Serum albumin ≥2.8 g/dL
- Renal function with serum creatinine ≤1.5 times upper limit or creatinine clearance >60 mL/min
- Coagulation function with INR ≤1.5 and APTT ≤1.5 times upper limit
- Voluntary agreement to participate, signed informed consent, and ability to comply with study visits and procedures
You will not qualify if you...
- History of other malignancies except certain treated cancers with no recurrence within 5 years
- Active or history of autoimmune disease including neurologic and connective tissue disorders; type 1 diabetes controlled with stable insulin is allowed
- Severe allergies or hypersensitivity to macromolecular proteins or PD-1 monoclonal antibody components
- Prior treatment with PD-1, PD-L1, CTLA-4, EGFR antibodies, tyrosine kinase inhibitors, antitumor vaccines, or recent live vaccines within 4 weeks
- Major surgery or severe trauma within 4 weeks before first dose
- Need for systemic corticosteroids over 10 mg/day prednisone or equivalent within 14 days before study drug
- Severe medical diseases including significant heart dysfunction, arrhythmias, or ECG abnormalities posing added risk
- History or suspicion of interstitial lung disease, active or uncontrolled tuberculosis
- Hyperthyroidism or uncontrolled thyroid disease; hypothyroidism controlled with replacement is allowed
- Active infections, unexplained fever before first dose, or recent use of systemic antibiotics
- Active hepatitis B or C infection, HIV infection, or AIDS
- History of neurologic or psychiatric disorders such as epilepsy or dementia
- History of drug or alcohol abuse within 3 months before enrollment
- Pregnancy, lactation, or unwillingness to use adequate contraception during and after study
- Use of investigational drugs within 4 weeks before study or participation in other clinical trials
- Any condition that may interfere with study participation, treatment completion, or follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, China
Actively Recruiting
Research Team
H
Huaju yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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