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Brief Title: Evaluate the Safety and Efficacy of Toripalimab Combined With Bevacizumab Versus Sorafenib Therapy for HCC
Official Title: A Randomized, Open-label, Multi-center Phase III Clinical Study to Evaluate the Safety and Efficacy of Toripalimab (JS001) Combined With Bevacizumab Versus Sorafenib as First-line Therapy for Advanced Hepatocellular Carcinoma
Study ID: NCT04723004
Brief Summary: This is a prospective, randomized, open-label, parallel-group, active controlled, multi-center phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab (hereafter referred to as JS001) combined with Bevacizumab versus Sorafenib as the first-line therapy for advanced HCC This study will enroll the patients with locally advanced or metastatic hepatocellular carcinoma who could not be radically cured and not receive any prior systemic therapy. The study will use PFS and OS as the co-primary endpoints, with approximately 280 patients planned to be enrolled.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The First Affiliated Hospital of Bengbu Medical college, Bengbu, Anhui, China
Anhui Cancer Hospital, Hefei, Anhui, China
Anhui Provincial Hospital, Hefei, Anhui, China
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Beijing Cancer Hospital, Beijing, Beijing, China
China PLA General Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Army Medical Center of PLA, Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
The Southwest Hospital Of AMU, Chongqing, Chongqing, China
The Frist Hospital of Lanzhou University, Lanzhou, Gansu, China
Gansu Wuwei Tumor Hospital, Wuwei, Gansu, China
The First Peoples Hospital of Foshan, Foshan, Guangdong, China
Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China
SSun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Yuebei People's Hospital, Shaoguan, Guangdong, China
Hainan General Hospital, Haikou, Hainan, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
he First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Henan Provincial Cancer Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Xiangya Hospital of Central South University, Changsha, Hunan, China
NanJing Drum Tower Hospital, Nanjing, Jiangsu, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University, Ganzhou, Jiangxi, China
The first Affiliated hospital of Nanchang University, Nanchang, Jiangxi, China
The Second Affiliated hospital of Nanchang University, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
Jilin Guowen Hospital, Changchun, Jilin, China
Liaoning cancer hospital, Shenyang, Liaoning, China
Shandong Cancer Hospital, Jinan, Shandong, China
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
First Affiliated Hospital of Xian Jiaotong University, Xi'an, Shanxi, China
Xi'an International Medical Center Hospital, Xi'an, Shanxi, China
Sichuan Cancer Hospital, Chengdu, Sichuan, China
West China Hospital,Sichuan University, Chengdu, Sichuan, China
Kaohsiung Medical University Chung-Ho Memorial Hospital, Gaoxiong, Taiwan, China
MacKay Memorial Hospital, Taibei, Taiwan, China
Changhua Christian Hospital, Zhanghua, Taiwan, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Yunnan Cancer Hospital, Kunming, Yunnan, China
ShuLan(HangZhou) Hospital, Hangzhou, Zhejiang, China
The First Affiliated Hospital,Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
ZheJiang Cancer Hospital, Hangzhou, Zhejiang, China
ZheJiang Provincial People's Hospital, Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Tongji Hospital Tongji Medical College Of HUST, Wuhan, Zhejiang, China
Xiehe Hospital Tongji Medical College Of HUST, Wuhan, Zhejiang, China
Zhongnan Hospital of Wuhan University, Wuhan, Zhejiang, China
Jia Fan, Shanghai, , China
Curie Oncology, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore