Phase 3 Study of Adding Camrelizumab to Chemotherapy and Radiotherapy for High-risk Nasopharyngeal Cancer

What this Trial Is About

Researchers are evaluating the addition of PD-1 treatment to chemo-radiotherapy for high-risk patients with nasopharyngeal carcinoma. This study is a multicenter, open-label, randomized clinical trial comparing outcomes between patients receiving combined PD-1 therapy with chemo-radiotherapy and those receiving chemo-radiotherapy alone. The goal is to see if the combined approach can reduce disease progression and improve survival. Participants are randomly assigned to one of two groups. One group receives three cycles of gemcitabine and cisplatin induction chemotherapy followed by concurrent chemo-radiotherapy with camrelizumab given intravenously during radiotherapy and continued for one year after. The other group receives the same chemotherapy and chemo-radiotherapy without camrelizumab. Radiotherapy is delivered using specific dosing schedules across several target volumes. During the study, participants undergo regular assessments including monitoring for disease progression, survival, treatment-related complications, and quality of life using standardized questionnaires. The primary outcome measured is progression-free survival over three years, with secondary outcomes including overall survival, metastasis-free survival, relapse-free survival, and treatment safety. The total study period extends up to three years for follow-up and evaluation.

Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma