研究单位：[1]Cstone Pharmaceuticals[2]Southern California Research Center,Coronado,California,United States,92118[3]Inland Empire Liver Foundation,Rialto,California,United States,92377[4]Mercy Medical Center,Baltimore,Maryland,United States,21202[5]UMass Memorial Medical Center,Worcester,Massachusetts,United States,01655[6]Stony Brook University Cancer Clinical Trials,Stony Brook,New York,United States,11794[7]The First Affiliated Hospital of Bengbu Medical College,Bengbu,Anhui,China[8]The First Affiliated Hospital Of Anhui Medical University,Hefei,Anhui,China[9]The Second Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China[10]Beijing Cancer Hospital,Beijing,Beijing,China[11]Beijing You'an Hospital, Capital Medical University,Beijing,Beijing,China[12]Peking Union Medical College Hospital,Beijing,Beijing,China[13]The 900th Hospital of Joint Logistic Support Force of PLA,Fuzhou,Fujian,China[14]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China[15]Foshan First People's Hospital,Foshan,Guangdong,China[16]Nanfang Hospital,Guangzhou,Guangdong,China[17]The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou,Guangdong,China[18]Guangxi Medical University Affiliated Tumor Hospital,Nanning,Guangxi,China[19]Hainan General Hospital - Hepatology,Haikou,Hainan,China[20]Harbin Medical University Cancer Hospital,Harbin,Heilongjiang,China[21]Luoyang Central Hospital,Luoyang,Henan,China[22]Henan Cancer Hospital,Zhengzhou,Henan,China[23]Zhengzhou University - First Affiliated Hospital,Zhengzhou,Henan,China[24]hubei Cancer Hospital,Wuhan,Hubei,China[25]Tongji Hospital - Medical Oncology,Wuhan,Hubei,China肿瘤科[26]Hunan Cancer Hospital - Radiology,Changsha,Hunan,China[27]Hunan Provincial People's Hospital,Changsha,Hunan,China[28]The Third Xiangya Hospital of Central South University,Changsha,Hunan,China[29]The First People's Hospital of Huai'an,Huai'an,Jiangsu,China[30]Nantong Tumor Hospital,Nantong,Jiangsu,China[31]The Second Affiliated Hospital of Soochow University,Suzhou,Jiangsu,China[32]Xuzhou Central Hospital,Xuzhou,Jiangsu,China[33]The Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China[34]Yanbian University Hospital,Yanbian,Jilin,China[35]Jinan Military Region General Hospital of the People's Liber,Jinan,Shandong,China[36]Shangdong Provicial Qianfoshan Hospital,Jinan,Shandong,China[37]Affiliated Hospital Of Jining Medical University,Jining,Shandong,China[38]Linyi Cancer Hospital,Linyi,Shandong,China[39]The Affiliated Hospital of Qingdao University,Qingdao,Shandong,China[40]Zhongshan Hospital, Fudan University,Shanghai,Shanghai,China,201203[41]Shanghai Cancer Hospital of Fudan University,Shanghai,Shanghai,China[42]Shanghai Eastern Hepatobiliary Surgery Hospital - Hepatology,Shanghai,Shanghai,China[43]Shanghai First People's Hospital,Shanghai,Shanghai,China[44]Sichuan University - West China Hospital,Chengdu,Sichuan,China[45]Tianjin Medical University - Cancer Institute & Hospital - Oncology,Tianjin,Tianjin,China[46]Zhejiang Cancer Hospital,Hangzhou,Zhejiang,China[47]Azienda Unità Locale Socio Sanitaria n. 1 Dolomiti, Distretto di Feltre, Ospedale di Feltre,Feltre,Belluno,Italy[48]Istituto Oncologico Veneto IOV IRCCS - Medical Oncology Unit 1,Padova,Veneto,Italy[49]Casa di Cura Dott. Pederzoli S.p.A (Ospedale Pederzoli),Peschiera Del Garda,Verona,Italy[50]PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology,Cremona,Italy[51]Fondazione IRCCS Policlinico San Matteo,Pavia,Italy[52]Centrum Badan Klinicznych,Wroclaw,Dolnoslaskie,Poland[53]MED-POLONIA Sp.z o.o.,Poznan,Wielkopolskie,Poland[54]Centrum Onkologii im. prof. F. Lukaszczyka,Bydgoszcz,Poland[55]Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy,Warszawa,Poland[56]Hospital Universitario Central de Asturias,Oviedo,Asturias,Spain[57]Complexo Hospitalario Universitario A Coruña,A Coruna,Galicia,Spain[58]Complejo Hospitalario Universitario
研究目的：
This is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Nofazinlimab (CS1003) in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular carcinoma (HCC). Subjects cannot be eligible for locoregional therapy. In this study, Nofazinlimab (CS1003) (or placebo) and lenvatinib are both considered as the study treatment while Nofazinlimab (CS1003) (or placebo) is the investigational product of and lenvatinib is selected as the basic treatment for HCC.
