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Brief Title: Sintilimab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma
Official Title: Sintilimab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma: a Randomized, Multicenter, Phase 3 Trial
Study ID: NCT03700476
Brief Summary: The CONTINUUM trial plans to enroll patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or the same regimen plus Sintilimab. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 12 cycles.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
First People's Hospital of Foshan, Foshan, Guangdong, China
Panyu central hospital, Guangzhou, Guangdong, China
SUN YAT-SEN UNIVERSITY cANCER CENTER, Guangzhou, Guangdong, China
Cancer Hospital of Guangxi Medical University, Nanning, Guangxi, China
Cancer Hospital of Guizhou Medical University, Guiyang, Guizhou, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiangya Hospital Central South University, Changsha, Hunan, China
Xijing Hospital, Fourth Military Medical University, Xi'an, Shanxi, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Name: Jun Ma, MD
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR