Comparing Adjuvant Therapy and Endoscopic Surgery Alone for Early-stage Recurrent Nasopharyngeal Carcinoma in a Multicenter Phase 3 Randomized Trial

What this Trial Is About

Researchers are investigating treatments for early-stage recurrent nasopharyngeal carcinoma, a type of cancer that returns in the nasopharynx area. This multicenter, randomized clinical trial compares the effects of adjuvant therapy, including chemotherapy and immunotherapy, with endoscopic surgery alone. The study aims to evaluate disease-free survival and other outcomes in patients with this condition. Participants are randomly assigned to one of two groups. The control group undergoes observation and follow-up after endoscopic surgery, while the experimental group receives adjuvant therapy consisting of four to six cycles of chemotherapy with a gemcitabine-based regimen and up to ten cycles of immunotherapy using Toripalimab Injection. Treatment continues until completion or unacceptable side effects occur. During the study, participants will be closely monitored through regular assessments to measure disease-free survival, overall survival, local recurrence, and distant metastasis rates up to 24 to 60 months. Follow-up includes evaluations of health status and cancer progression. The total participation period may extend up to five years, including safety monitoring and outcome assessments.

Adjuvant vs Surgery Only in Early-stage Recurrent NPC