Spots Global Cancer Trial Database for The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer
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Trial Identification
Brief Title: The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer
Official Title: A Phase III, Randomized, Placebo Controlled, Multicenter, Double-Blind Study Comparing Toripalimab Injection (JS001) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer
Study ID: NCT03581786
Conditions
Study Description
Brief Summary: This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3 weeks (Q3W) in 3-week cycles.
Detailed Description: Total 289 patients were enrolled and randomized in a 1:1 ratio to the group of JS001 (Arm A) with gemcitabine and cisplatin or placebo (Arm B) with gemcitabine and cisplatin every 3 weeks (Q3W) in the 'during chemotherapy' phase. During the 'post-chemotherapy' phase, patients randomized to Arm A or Arm B will continue treatment with JS001 or placebo as maintenance therapy Q3W until excessive toxicity or progressive disease, withdrawal of consent or Investigator's judgement or a maximum of 2 years. Tumor evaluation scans will be performed at screening (as baseline) then every 6weeks in the first 12 months then every 9 weeks thereafter until objective disease progression. The primary objective is to compare PFS as assessed by the IRC in ITT population (all randomized patients).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
Nanfang Hospital, Guangzhou, Guangdong, China
Shenzhen People's Hospital, Shenzhen, Guangdong, China
Liuzhou Worker's Hospital, Liuzhou, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
Cancer Hospital of Shantou University Medical College, Shantou, Guangzhou, China
Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangzhou, China
The Fifth Affiliated Hospital Sun Yat-Sen University - Medical Oncology, Zhuhai, Guangzhou, China
Guizhou Cancer Hospital_Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
Hainan General Hospital (Hainan Province People's Hospital), Haikou, Hainan, China
Hebei Oncology Hospital, Shijiazhuang, Hebei, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyTongji Hospital, Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangsu Oncology Hospital, Nanjing, Jiangsu, China
Jiangxi Cancer Hospital, Nanchang, Jiangxi, China
Fudan University Cancer Hospital, Shanghai, Shanghai, China
Shanghai first people's hospital, Shanghai, Shanghai, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
National Cancer Centre, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore
China Medical University Hospital, Taichung City, , Taiwan
TaiChung Veterans General Hospital, Taichung City, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Contact Details
Name: Ruihua Xu, Ph.D
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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