Phase II Study of Multi-target Radiotherapy with PD-1 Antibody and Capecitabine Maintenance for Oligometastatic Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating a combination treatment for patients with oligometastatic nasopharyngeal carcinoma, a type of cancer that has spread but only to a limited number of sites. This phase II clinical trial is designed to assess how effective and safe multi-target radiotherapy combined with a PD-1 monoclonal antibody and capecitabine maintenance therapy is for this condition. The study also aims to explore genetic markers and develop models to predict which patients may benefit from this treatment approach. Participants will receive a combination of radiotherapy, chemotherapy, and immunotherapy. Radiotherapy involves intensity-modulated radiation therapy IMRT targeting primary tumor sites and cervical lymph nodes, along with stereotactic body radiation therapy SBRT directed at oligometastatic sites. The PD-1 inhibitor is administered intravenously every three weeks throughout the trial. Capecitabine is taken orally twice daily at 650 mg following radiotherapy and continued for one year as maintenance therapy. During the study, participants will be closely monitored through various assessments to evaluate treatment response, progression-free survival at two years, overall survival, and duration of response. Researchers will also gather safety data and explore potential genetic biomarkers related to treatment efficacy. The total participation period includes treatment and follow-up visits to track outcomes and safety until the study concludes.

Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma