Study of GV20-0251 Combined With Sintilimab as Pre-Surgery Treatment for Adults With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

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 mgkg or 20 mgkg 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 investigators 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.

GV20-0251 and Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm Study