Randomized Study of Sintilimab Maintenance Therapy After Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of maintenance therapy with Sintilimab after chemoradiotherapy in patients with locally advanced head and neck squamous cell carcinoma. This prospective, randomized, single-blind controlled clinical study aims to compare Sintilimab to a placebo in this patient population. The study focuses on how well Sintilimab works in preventing disease progression and its safety profile. Participants will start treatment within one month after completing chemoradiotherapy. The experimental group receives Sintilimab intravenously on the first day of each 21-day cycle, while the control group receives a placebo with the same schedule. Up to 18 treatment cycles are planned, or treatment continues until disease progression. Blood tests and electrocardiograms will be repeated every two cycles, and CT scans every four cycles to monitor toxicity, side effects, and cancer recurrence. During the study, participants will undergo regular assessments including laboratory tests, imaging, and quality of life questionnaires. Researchers will track progression-free survival over one and three years as primary outcomes and will also evaluate overall survival, safety, tolerability, and quality of life over three years. The total participation period covers treatment cycles and follow-up evaluations to monitor long-term outcomes.

A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood