NCT03907826

PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients

PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

Conditions

• Recurrent Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	PD-1 blocking antibody	Toripalimab 240mg, D1, every 3 weeks per cycle
DRUG	GP	Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
RADIATION	IMRT	IMRT 60-66Gy, 1.8-2.0Gy/f/day

Timeline

• Start date: 2020-03-01
• Primary completion: 2025-12-01
• Completion: 2028-12-01
• First posted: 2019-04-09
• Last updated: 2025-01-28

Locations

12 sites across 1 country: China