Phase III Trial of PD-1 Antibody with Chemoradiotherapy Versus Chemoradiotherapy Alone for Recurrent Nasopharyngeal Carcinoma in Adults

What this Trial Is About

Researchers are evaluating the effects of combining a PD-1 antibody with chemoradiotherapy compared to chemoradiotherapy alone in patients with recurrent nasopharyngeal carcinoma. This multicenter, randomized phase III clinical trial aims to assess both the effectiveness and side effects of these treatments in this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive three cycles of the PD-1 antibody JS001, 240mg every three weeks combined with GP chemotherapy, followed by intensity-modulated radiation therapy IMRT and maintenance PD-1 antibody for eight cycles. The other group will receive three cycles of GP chemotherapy followed by IMRT alone. Throughout the study, participants will be monitored for overall survival over three years, progression-free survival, short-term treatment effects, rates of acute toxicities, and quality of life using the EuroQoL 5 dimension questionnaire. The study involves ongoing assessments including physical exams, laboratory tests, and safety monitoring. The total duration includes treatment and follow-up periods extending up to three years.

PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients