Actively Recruiting
GV20-0251 Combined With Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Study
Led by West China Hospital · Updated on 2026-03-25
9
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether neoadjuvant treatment with GV20-0251 combined with sintilimab is safe, tolerable, and shows early signs of antitumor activity in adults with resectable, locally advanced head and neck squamous cell carcinoma. The study focuses on identifying dose-limiting toxicities during treatment and measuring the major pathological response in tumor tissue after surgery. This is a Phase 1, single-arm clinical trial conducted at West China Hospital, Sichuan University. Participants receive two 3-week cycles of neoadjuvant therapy with GV20-0251 at either 10 mg/kg or 20 mg/kg plus a fixed 200 mg dose of sintilimab, both given by intravenous infusion on Day 1 of each cycle. After this, participants undergo surgery to remove the tumor. Following surgery, they receive postoperative adjuvant therapy consisting of sintilimab infusions every 3 weeks for 15 cycles along with the investigator's choice of standard radiotherapy, with or without cisplatin chemotherapy given for up to 9 weeks. During the study, participants will be closely monitored for safety through regular clinical assessments, laboratory tests, and adverse event tracking based on standard criteria. Researchers will evaluate tumor responses at surgery and measure outcomes such as event-free survival over up to 2 years. Participants will also complete follow-up visits to monitor disease status and survival after treatment. The total study duration includes the neoadjuvant phase, surgery, adjuvant therapy, and long-term safety and efficacy follow-up.
CONDITIONS
Brief 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 18 to 70 years, male or female
- Histologically confirmed locally advanced head and neck squamous cell carcinoma suitable for surgery
- Newly diagnosed without distant metastasis (specific staging and HPV status required)
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function as defined by blood counts and lab tests
- Able and willing to provide informed consent and comply with study procedures
You will not qualify if you...
- History of other recent or active malignancies except certain treated skin or bladder cancers
- Active or history of autoimmune diseases, except controlled type 1 diabetes
- Severe allergies or hypersensitivity to study drug components
- Prior treatment with PD-1, PD-L1, CTLA-4 antibodies, EGFR inhibitors, or antitumor vaccines
- Recent live vaccines or major surgery within 4 weeks before study drug
- Need for systemic corticosteroids or immunosuppressants above allowed doses
- Severe cardiac conditions or abnormal ECG findings posing risk
- History or suspicion of lung disease or active infections including hepatitis B, C, or HIV
- Neurologic or psychiatric disorders like epilepsy or dementia
- Recent drug or alcohol abuse
- Pregnancy, lactation, or unwillingness to use contraception
- Recent participation in other investigational drug studies
- Any condition interfering with study participation or completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive neoadjuvant treatment with GV20-0251 and sintilimab by intravenous infusion every 21 days for 2 cycles prior to surgery.
2 visits (in-person) corresponding to each treatment cycle
Duration - 1 week or as per standard surgical recovery
Participants undergo planned surgical resection following neoadjuvant treatment.
1 visit (in-person) for surgery
Duration - Up to approximately 48 weeks
Participants receive adjuvant treatment with sintilimab by intravenous infusion every 21 days for 15 cycles, combined with investigator's choice of standard-of-care radiotherapy, with or without cisplatin chemotherapy for up to 9 weeks.
15 visits for sintilimab infusion plus additional visits for radiotherapy and chemotherapy as per standard care
Duration - Up to 2 years
Participants are monitored for adverse events and event-free survival after completion of treatment.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, China
Actively Recruiting
Research Team
H
Huaju yang
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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