Phase II Study of Immune Maintenance Therapy with Toripalimab for Adults Aged 18 to 80 With Locally Advanced Head and Neck Squamous Cell Carcinoma After Neoadjuvant Immunotherapy and Chemotherapy

What this Trial Is About

Researchers are evaluating immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who have achieved a major pathological response MPR after receiving neoadjuvant immunotherapy combined with chemotherapy. This study addresses the high morbidity and mortality of head and neck cancer, where standard treatments offer limited clinical benefit and survival rates are low. The goal is to assess the effectiveness and safety of this immune maintenance treatment following initial therapy. The study compares two groups one receiving toripalimab as immune maintenance therapy intravenously at 240 mg every three weeks for up to 15 cycles, and the other receiving standard concurrent radiochemotherapy or postoperative radiotherapy. This phase II trial is randomized and conducted at a single center, focusing on patients who have already responded well to initial combined neoadjuvant immunotherapy and chemotherapy. Participants will be monitored for disease-free survival for up to four years, with additional evaluations of overall survival and adverse events for up to one year. The study involves regular assessments of physical health, laboratory tests for bone marrow, liver, and kidney function, and safety monitoring. Follow-up visits will include evaluations of treatment response and potential side effects to ensure participant safety throughout the trial period.

A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy