研究单位:[1]Shanghai Junshi Bioscience Co., Ltd.[2]The First Affiliated Hospital of Bengbu Medical college,Bengbu,Anhui,China,233000[3]Anhui Cancer Hospital,Hefei,Anhui,China,230000[4]Anhui Provincial Hospital,Hefei,Anhui,China,230000[5]The Second Hospital of Anhui Medical University,Hefei,Anhui,China,230000[6]Beijing Cancer Hospital,Beijing,Beijing,China,100000[7]China PLA General Hospital,Beijing,Beijing,China,100000[8]Peking Union Medical College Hospital,Beijing,Beijing,China,100000[9]Army Medical Center of PLA,Chongqing,Chongqing,China,400000[10]The First Affiliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China,400000[11]The Southwest Hospital Of AMU,Chongqing,Chongqing,China,400000[12]The Frist Hospital of Lanzhou University,Lanzhou,Gansu,China,730000[13]Gansu Wuwei Tumor Hospital,Wuwei,Gansu,China,733000[14]The First Peoples Hospital of Foshan,Foshan,Guangdong,China,528000[15]Nanfang Hospital of Southern Medical University,Guangzhou,Guangdong,China,510000[16]SSun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510000[17]Sun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510000[18]The First Affiliated Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510000[19]Yuebei People's Hospital,Shaoguan,Guangdong,China,512000[20]Hainan General Hospital,Haikou,Hainan,China,570100[21]Harbin Medical University Cancer Hospital,Harbin,Heilongjiang,China,150000[22]he First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450000[23]Henan Provincial Cancer Hospital,Zhengzhou,Henan,China,450000[24]Hubei Cancer Hospital,Wuhan,Hubei,China,430000[25]Hunan Cancer Hospital,Changsha,Hunan,China,410000[26]Xiangya Hospital of Central South University,Changsha,Hunan,China,410000[27]NanJing Drum Tower Hospital,Nanjing,Jiangsu,China,210000[28]Nantong Tumor Hospital,Nantong,Jiangsu,China,226000[29]The Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu,China,221000[30]The First Affiliated Hospital of Gannan Medical University,Ganzhou,Jiangxi,China,341000[31]The first Affiliated hospital of Nanchang University,Nanchang,Jiangxi,China,330000[32]The Second Affiliated hospital of Nanchang University,Nanchang,Jiangxi,China,330000[33]Jilin Cancer Hospital,Changchun,Jilin,China,130000[34]Jilin Guowen Hospital,Changchun,Jilin,China,130000[35]Liaoning cancer hospital,Shenyang,Liaoning,China,110000[36]Shandong Cancer Hospital,Jinan,Shandong,China,250000[37]The Affiliated Hospital of Qingdao University,Qingdao,Shandong,China,266000[38]First Affiliated Hospital of Xian Jiaotong University,Xi''an,Shanxi,China,710000[39]Xi''an International Medical Center Hospital,Xi''an,Shanxi,China,710000[40]Sichuan Cancer Hospital,Chengdu,Sichuan,China,610000[41]West China Hospital,Sichuan University,Chengdu,Sichuan,China,610000[42]Kaohsiung Medical University Chung-Ho Memorial Hospital,Gaoxiong,Taiwan,China,000800[43]MacKay Memorial Hospital,Taibei,Taiwan,China,100[44]Changhua Christian Hospital,Zhanghua,Taiwan,China,000500[45]Tianjin Medical University Cancer Institute & Hospital,Tianjin,Tianjin,China,300000[46]Yunnan Cancer Hospital,Kunming,Yunnan,China,650000[47]ShuLan(HangZhou) Hospital,Hangzhou,Zhejiang,China,310000[48]The First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou,Zhejiang,China,310000[49]ZheJiang Cancer Hospital,Hangzhou,Zhejiang,China,310000[50]ZheJiang Provincial People''s Hospital,Hangzhou,Zhejiang,China,310000[51]The First Affiliated Hospital of Wenzhou Medical University,Wenzhou,Zhejiang,China,325000[52]Tongji Hospital Tongji Medical College Of HUST,Wuhan,Zhejiang,China,430000[53]Xiehe Hospital Tongji Medical College Of HUST,Wuhan,Zhejiang,China,430000[54]Zhongnan Hospital of Wuhan University,Wuhan,Zhejiang,China,430000[55]Jia Fan,Shanghai,China,130061[56]Curie Oncology,Singapore,Singapore,999002[57]Tan Tock Seng Hospital,Singapore,Singapore,999002
研究目的:
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.