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Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
Sponsor: Sun Yat-sen University
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
Conditions
Interventions
Toripalimab
240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT
Chemotherapy
Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
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