Phase 3 Trial Comparing Camrelizumab With and Without Stereotactic Body Radiotherapy for Oligometastatic Nasopharyngeal Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining immunotherapy with stereotactic body radiotherapy SBRT versus immunotherapy alone for patients with oligometastatic nasopharyngeal carcinoma. This trial focuses on patients whose primary tumors have been well controlled after radical local-regional treatment. The goal is to determine whether adding SBRT to immunotherapy can potentially cure some patients with distant metastases and improve overall survival in this multicenter randomized phase 3 study. Participants are assigned randomly to one of two groups. One group receives camrelizumab, a drug given by intravenous infusion every two weeks, starting two weeks before radiotherapy they then receive stereotactic body radiotherapy targeting oligometastatic lesions until disease progression, unacceptable side effects, or one year of treatment. The other group receives camrelizumab alone every two weeks under the same conditions. The radiation doses for SBRT follow established clinical study guidelines. During the study, participants will have regular assessments including scans and clinical evaluations to monitor disease status and treatment effects. Researchers will measure outcomes such as median progression-free survival over two years, response rates, overall survival, adverse events, and quality of life scores using validated questionnaires. Safety and treatment adherence will be closely observed throughout the treatment period. The total duration of participation depends on disease progression, treatment tolerance, and study criteria over the two-year observation period.

Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma