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A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

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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.

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