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RECRUITING
NCT05340491
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: Chemoradiotherapy Combined With Programmed Death 1 Antibody in Recurrent Nasopharyngeal Carcinoma: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

212

Start Date

2022-04-01

Completion Date

2027-12

Last Updated

2022-08-31

Healthy Volunteers

No

Interventions

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

Locations (12)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Peking University Third Hospital

Beijing, China

Sichuan Cancer Hospital

Chengdu, China

Fujian Province Cancer Hospital

Fuzhou, China

Guizhou Cancer Hospital

Guiyang, China

Zhejiang Cancer Hospital

Hangzhou, China

Jiangxi Cancer Hospital

Nanchang, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Fudan University Shanghai Cancer Center

Shanghai, China

Zhongnan Hospital of Wuhan University

Wuhan, China

Xijing Hospital

Xi'an, China

The First Affiliated Hospital of Xiamen University

Xiamen, China