Evaluating Reduced Surgery Versus Standard Surgery After Immunotherapy in Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

This research evaluates the effectiveness and safety of less extensive de-escalated surgery compared to standard surgery in patients with resectable locally advanced head and neck squamous cell carcinoma LA-HNSCC who have shown a partial or complete response after neoadjuvant immunochemotherapy. The goal is to see if reducing surgery extent can maintain cancer control while improving postoperative function and quality of life. This exploratory, randomized, controlled clinical trial will enroll 60 patients over three years. Participants will be randomly assigned to either the experimental group receiving de-escalated surgery, which involves smaller tumor removal margins, preservation of key anatomical structures, and selective neck dissection based on clinical response, or the control group receiving standard surgery following established guidelines, including wide excision and comprehensive neck dissection. Imaging assessments using CT or MRI and RECIST 1.1 criteria will guide treatment decisions and monitor response at multiple time points before and after surgery. During the study, patients will undergo evaluations including imaging scans at baseline, before surgery, and regularly every three months for up to two years or until recurrence or study completion. Quality of life will be measured using specific questionnaires at baseline, one month after surgery, and during follow-ups. Researchers will track disease-free survival, overall survival rates at 3 and 5 years, and safety outcomes. The trial aims to provide evidence on whether a tailored surgical approach can improve patient quality of life without compromising survival.

Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma