Study Comparing Neoadjuvant and Adjuvant Therapies Combined With Endoscopic Surgery for Advanced Recurrent Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are studying treatments for adults with locally advanced recurrent nasopharyngeal carcinoma, a type of cancer that has returned in the nasopharynx area. This Phase 3 randomized controlled trial compares two approaches surgery combined with both neoadjuvant before surgery and adjuvant after surgery therapy versus surgery combined with adjuvant therapy alone. The study aims to evaluate outcomes like event-free survival and other effectiveness measures to better understand treatment options. Participants are randomly assigned to one of two groups. The experimental group receives two courses of neoadjuvant therapy, including Toripalimab Injection and Gemcitabine-based chemotherapy, before endoscopic surgery. After surgery, they continue with two to four courses of chemotherapy and eight courses of immunotherapy. The control group undergoes endoscopic surgery first, followed by four to six courses of chemotherapy and ten courses of immunotherapy. Treatments continue until unacceptable side effects occur or planned courses are complete. During the study, participants will undergo assessments such as pathological tumor evaluation two weeks after surgery, imaging evaluations before treatment and surgery, and monitoring for progression, recurrence, and survival up to five years. Researchers will track event-free survival for one year and other secondary outcomes including overall survival, disease-free survival, local and distant recurrence, response rates, and safety. The total participation period extends through treatment and follow-up visits, allowing detailed evaluation of treatment effects and safety.

Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC