Phase III Study of Chemoradiotherapy With or Without Anti-PD-1 Antibody Toripalimab in Adults With Recurrent Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining an anti-PD-1 antibody with chemoradiotherapy compared to chemoradiotherapy alone in patients with recurrent nasopharyngeal carcinoma. This phase III, open-label, randomized, controlled trial involves multiple centers and is sponsored by Sun Yat-sen University. It aims to assess overall survival and other important health outcomes over several years. Participants are randomly assigned to one of two groups. One group receives three cycles of gemcitabine and cisplatin chemotherapy plus the PD-1 antibody Toripalimab, followed by intensity modulated radiotherapy IMRT and eight maintenance cycles of Toripalimab. The other group receives the same chemotherapy regimen followed by IMRT alone. Radiation is delivered at a total dose of 60-66 Gy over daily fractions. During the study, participants undergo regular assessments including survival monitoring, tumor response, disease control, and evaluation of side effects such as nasopharyngeal necrosis and hemorrhage. Quality of life is also tracked up to three years. Safety assessments use standard toxicity criteria, and the total follow-up period extends to three years to evaluate both acute and late toxicities and overall treatment impact.

Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial