A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)
研究单位:[1]Chia Tai Tianqing Pharmaceutical Group Co., Ltd.[2]The First Affiliated Hospital of Bengbu Medical College,Bengbu,Anhui,China,233004[3]Anhui Provincial Hospital,Hefei,Anhui,China,230001[4]The First Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China,230022[5]Anhui Provincial Cancer Hospital,Hefei,Anhui,China,230031[6]Beijing Ditan Hospital.Capital Medical University,Beijing,Beijing,China,100015[7]Beijing YouAn Hospital.Capital Medical University,Beijing,Beijing,China,100069[8]Peking Union Medical College Hospital,Beijing,Beijing,China,100730[9]Chinese Pla General Hospital,Beijing,Beijing,China,100853[10]Beijing Tsinghua Changgung Hospital,Beijing,Beijing,China,102218[11]Beijing Luhe Hospital.Capital Medical University,Beijing,Beijing,China[12]The Second Affiliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China,400010[13]Chongqing University Three Gorges Hospital,Chongqing,Chongqing,China,404031[14]The First Affiliated Hospital of Fujian Medical University,Fuzhou,Fujian,China,350005[15]Fujian Provincial Cancer Hospital,Fuzhou,Fujian,China,350014[16]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China,361003[17]Zhongshan Hospital Xiamen University,Xiamen,Fujian,China,361004[18]The first hospital of Lanzhou University,Lanzhou,Gansu,China,730000[19]Lanzhou University Second Hospital,Lanzhou,Gansu,China,730030[20]Gansu Wuwei Tumour Hospital,Wuwei,Gansu,China,733000[21]Guangdong Provincial People''s Hospital,Guangzhou,Guangdong,China,510080[22]Sun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510289[23]The First Affiliated Hospital,Sun Yat-sen University,Guangzhou,Guangdong,China[24]Guangxi Medical University Affiliated Tumor Hospital,Nanning,Guangxi Zhuang Autonomous Region,China,530021[25]The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi Zhuang Autonomous Region,China,530021[26]The Second Nanning People''s Hospital,Nanning,Guangxi,China,530031[27]Guizhou Provincial People''s Hospital,Guiyang,Guizhou,China,550002[28]Cancer Hospital of Guizhou Medical University,Guiyang,Guizhou,China,550081[29]Affiliated Hospital of Zunyi Medical University,Zunyi,Guizhou,China,563099[30]Hainan General Hospital,Haikou,Hainan,China,570311[31]The Second Affiliated Hospital of Hainan Medical Universit,Haikou,Hainan,China,570311[32]The Third Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050051[33]First Hospital Of Qinhuangdao,Qinhuangdao,Hebie,China,350014[34]Affiliated Hospital of Chengde Medical University,Chengde,Heibei,China,67020[35]Affiliated Tumor Hospital of Harbin Medical University,Harbin,Heilongjiang,China,150081[36]The First Affiliated Hospital of Henan University of Science and Technology,Luoyang,Henan,China,471003[37]Nanyang First People''s Hospita,Nanyang,Henan,China,473006[38]Sanmenxia Central Hospital,Sanmenxia,Henan,China,472000[39]Xinxiang central hospital,Xinxiang,Henan,China,453000[40]Henan Cancer Hospital,Zhengzhou,Henan,China,450008[41]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450052[42]Zhongnan Hospital of Wuhan University,Wuhan,Hubei,China,430071[43]Hubei Cancer Hospital,Wuhan,Hubei,China,430079[44]Xiangya Hospital Central South University,Changsha,Hunan,China,410008[45]Hunan Cancar Hospital,Changsha,Hunan,China,410013[46]The Third Xiangya Hospital of Central South University,Changsha,Hunan,China,410013[47]Hunan Provincial People''s Hospital,Changsha,Hunan,China,410021[48]Hunan Cancer Hospital(Department II of Gastroenterology and Urology/Hepatobiliary Surgery),Changsha,Hunan,China,410205[49]The First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu,China,210000[50]The Second Hospital of Nanjing,Nanjing,Jiangsu,China,210003[51]Jiangsu Cancer Hospital,Nanjing,Jiangsu,China,210029[52]Nantong Tumor Hospital,Nantong,Jiangsu,China,226361[53]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China,330006[54]Jilin Cancer Hospital,Changchun,Jilin,China,13000[55]The First Hospital Affiliated to Jilin Universit,Changchun,Jilin,China,130021[56]Jilin Guowen Hospital,Changchun,Jilin,China,130700[57]Gansu Provincial Hospital,Gansu,Lanzhou,China,730099[58]The First Affiliated Hospital of Jinzhou Medical University,Jinzhou,Liaoning,China,121012[59]The Sixth People''s Hospital Of Shenyang,Shenyang,Liaoning,China,110006[60]Liaoning Cancer Hospital,Shenyang,Liaoning,China,110042[61]Baoji Central Hospital,Baoji,Shaanxi,China,721000[62]Hanzhong Central Hospital,Hanzhong,Shaanxi,China,723000[63]Qilu Hospital of Shandong University,Jinan,Shandong,China,250012[64]Liaocheng people''s Hospital,Liaocheng,Shandong,China,252004[65]Yidu Central Hospital Of Weifang,Weifang,Shandong,China,262550[66]Fudan University Shanghai Cancer Center,Shanghai,Shanghai,China,200032[67]Zhongshan Hospital, Fuadn University,Shanghai,Shanghai,China,200032[68]The Third Affiliated Hospital of the Second Military Medical University of the Chinese people''s Liberation Army,Shanghai,Shanghai,China,201800[69]Shanxi Provinaial Cancer Hospital,Taiyuan,Shanxi,China,030013[70]Tangdu Hospital of the Fourth Military Medical University of the People''s Liberation Army of China,Xi''an,Shanxi,China,710038[71]First Affiliated Hospital of Xi''an Jiaotong University,Xi''an,Shanxi,China,710061[72]Shanxi Provincial Cancer Hospital,Xi''an,Shanxi,China,710061[73]Sichuan Cancer Hospital,Chengdu,Sichuan,China,610042[74]Affiliated Hospital of Chengdu University,Chengdu,Sichuan,China,610081[75]Affiliated Hospital of North Sichuan Medical College,Nanchong,Sichuan,China,637000[76]Tianjin Medical University Cancar institute & Hospital,Tianjin,Tianjin,China,300060[77]Tianjin Third Central Hospital,Tianjin,Tianjin,China,300170[78]Tianjin Second People''s Hospital,Tianjin,Tianjin,China,300192[79]The First Affiliated Hospital of Xinjiang Medical University,Ürümqi,Xinjiang Uygur Autonomous Region,China,830054[80]Shulan (Hangzhou) hospital,Hangzhou,Zhejiang,China,310015[81]The First Affiliated Hospital of Wenzhou Medical University,Wenzhou,Zhejiang,China,325000[82]Wenzhou People''s Hospital,Wenzhou,Zhejiang,China,325041
研究目的:
This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus Sorafenib. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or Sorafenib, with 2:1 random ratio. Every 21 days is a treatment cycle.