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

NCT Number	NCT07457281
Lead Sponsor	West China Hospital
Conditions	Head and Neck Squamous Cell Carcinoma HNSCC
Enrollment	9 participants
Start Date	2026-04-01
Primary Completion	2027-04-01 (estimated)
Study Completion	2028-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-25