Phase III Study Comparing PD-1 Inhibitor Therapy to Radiotherapy in Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy Showing Complete Pathologic Response

What this Trial Is About

Researchers are investigating whether PD-1 inhibitor therapy can replace adjuvant radiotherapy in patients with locally advanced head and neck squamous cell carcinoma HNSCC who have undergone neoadjuvant immunochemotherapy and standard surgery, achieving complete pathological response in both primary and lymph node sites. This Phase III randomized controlled trial aims to provide evidence for safer, targeted treatment options to avoid side effects associated with excessive radiotherapy, such as second primary cancers and radiation osteonecrosis. Participants are randomly assigned to one of two groups the experimental group receives a PD-1 inhibitor maintenance therapy every three weeks for six cycles, continuing the same monoclonal antibody used before surgery the control group receives conventional radiotherapy or concurrent chemoradiotherapy following current guidelines, including carboplatin or cisplatin with radiotherapy. This study is conducted at multiple centers and compares the long-term outcomes and safety of these two approaches. Participants will be followed for five years to measure overall survival and the incidence of severe adverse reactions related to treatment, using standardized criteria for radiotherapy toxicity and adverse event grading. Secondary outcomes include two-year disease-free survival, regional and distant relapse-free survival, and treatment-related adverse events. Researchers will also explore clinical and laboratory factors that may affect treatment efficacy. Safety evaluations focus on acute and late toxicities, and monitoring ensures participant adherence and wellbeing throughout the study period.

PD-1 Inhibitor Therapy Versus Radiotherapy in pCR Patients With Locally Advanced HNSCC After Neoadjuvant Immunochemotherapy