RecruitingPhase 1NCT07457281

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

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

Sponsor

West China Hospital

Enrollment

9 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

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. 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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining two immunotherapy drugs—GV20-0251 and sintilimab (which help the immune system attack cancer)—given before surgery (neoadjuvant treatment) can shrink head and neck squamous cell carcinoma (a common type of head and neck cancer) and improve surgical outcomes for patients whose cancer can still be surgically removed. **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with locally advanced head and neck squamous cell cancer (stages II–IVB, depending on location and HPV status) - Your surgeon has assessed the cancer as surgically removable - You have not had any prior treatment for this cancer - Your organ function meets the required levels **You may NOT be eligible if...** - You have had prior immunotherapy (anti-PD-1, anti-PD-L1, anti-EGFR) or related drugs - You have an active autoimmune disease or are on immunosuppressive drugs - You have a serious active infection, HIV, active hepatitis B or C - You have significant heart disease, lung problems, or epilepsy/dementia - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGV20-0251

GV20-0251 administered by intravenous infusion on a protocol-specified schedule as part of neoadjuvant treatment prior to surgery.

DRUGSintilimab

Sintilimab (PD-1 inhibitor) administered as neoadjuvant therapy in combination with GV20-0251 prior to planned surgery, according to the study protocol.