NCT05340491

Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

Chemoradiotherapy Combined With Programmed Death 1 Antibody in Recurrent Nasopharyngeal Carcinoma: A Multicenter, Open-label, Randomised, Controlled, Phase III 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, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab	240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT
DRUG	Chemotherapy	Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
RADIATION	Intensity modulated radiotherapy	total 60-66Gy, 1.8-2.0Gy/f/day

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-12-01
• Completion: 2027-12-01
• First posted: 2022-04-22
• Last updated: 2022-08-31

Locations

12 sites across 1 country: China