A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
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研究单位:[1]Jiangsu HengRui Medicine Co., Ltd.[2]University of California San Diego (UCSD)-Moores Cancer Center La Jolla, California, United States, 92037[3]University of California - Irvine Orange, California, United States, 92868[4]University of Maryland Baltimore, Maryland, United States, 21201[5]Cornell University Weill Cornell Medical College New York, New York, United States, 10065[6]The Center for Cancer and Blood Disorders Fort Worth, Texas, United States, 76104[7]MD Anderson Cancer Center Houston, Texas, United States, 77030[8]Renovatio Clinical The Woodlands, Texas, United States, 77380[9]Cliniques Universitaires de Bruxelles Hopital Erasme Bruxelles, Belgium, 1070[10]Cliniques Universitaires Saint-Luc Bruxelles, Belgium, 1200[11]UZA Edegem, Belgium, 2650[12]AZ Maria Middelares Gent, Belgium, 9000[13]AZ Groeninge Kortrijk, Belgium, 8500[14]Anhui Provincal Cancer Hospital Hefei, Anhui, China, 230000[15]Anhui Provincal Hospital Hefei, Anhui, China, 230000[16]The First Affiliated Hospital Of Anhui Medical University Hefei, Anhui, China, 230009[17]The Second Affiliated Hospital Of Anhui Medical University Hefei, Anhui, China, 230601[18]Chinese Academy of Medical Sciences Cancer Hospital Beijing, Beijing, China, 100020[19]Beijing cancer Hospital Beijing, Beijing, China, 100089[20]Peking University International Hospital Beijing, Beijing, China, 102206[21]The Second Hospital Affiliated To AMU Chongqing, Chongqing, China, 400037[22]The First Hospital Affiliated To AMU Chongqing, Chongqing, China, 400038[23]TheThird Affiliated Hospital ,Army Medical University Chongqing, Chongqing, China, 400042[24]The Second Affiliated Hospital of ChongQing Medical University Chongqing, Chongqing, China, 400060[25]Fujian Medical University Union Hospital Fuzhou, Fujian, China, 350001[26]The 940th Hospital of the joint logistic support force of People's Liberation Army Lanzhou, Gansu, China[27]Sun Yat-sen University Cancer Center Guangzhou, Guangdong, China, 510060[28]Sun Yat-sen Memorial Hospital, Sun Yat-Sen University Guangzhou, Guangdong, China, 510220[29]NanFang Hospital of Southern Medical University Guangzhou, Guangdong, China, 510515[30]The first affiliated hospital of guangxi medical university Nanning, Guangxi, China, 530021[31]The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 050011河北医科大学第四医院[32]Harbin Medical University Cancer Hospital Harbin, Heilongjiang, China, 150000[33]Wuhan Union Hospital,Tongji Medical College,Huazhong University of Science&Technology Wuhan, Hubei, China, 430022[34]Tongji hospital,Tongji Medical College,Huazhong University of Science&Technology Wuhan, Hubei, China, 430030[35]Hunan Cancer Hospital Changsha, Hunan, China, 410006[36]Eastern Theater General Hospital, Qinhuai District Medical Area Nanjing, Jiangsu, China, 210002[37]The First Affiliated Hospital Of Nanchang University Nanchang, Jiangxi, China, 330006[38]Jilin Cancer Hospital Changchun, Jilin, China, 130000[39]The First Hospital of Jilin University Changchun, Jilin, China, 130000[40]The Sixth People's Hospital of Shengyang Shengyang, Liaoning, China, 110006[41]Liaoning Cancer Hospital Shenyang, Liaoning, China, 110042[42]Shandong Cancer Hospital Affiliated to Shandong University Jinan, Shandong, China, 250000[43]Fudan University Shanghai Cancer Center Shanghai, Shanghai, China, 200032[44]Zhongshan Hospital, Fudan University Shanghai, Shanghai, China, 200032[45]Shanghai Changhai Hospital Shanghai, Shanghai, China, 200043[46]West China Hospital of Sichuan University Chengdu, Si Chuan, China, 610041[47]Sichuan Cancer Hospital&Institute Chengdu, Sichuan, China, 610054[48]Sir Run Run Shaw Hospital Hangzhou, Zhejiang, China, 310016[49]ZheJiang Cancer Hospital Hangzhou, Zhejiang, China, 310022[50]The First Affiliated Hospital, Zhejiang University Hangzhou, Zhejiang, China[51]Charite Universitaetsmedizin Berlin - Campus Virchow-Klinikum Berlin Berlin, Germany, 13353[52]Pamela Youde Nethersole Eastern Hospital Hong Kong, Hong Kong[53]The University of Hong Kong Hong Kong, Hong Kong[54]Tuen Mun Hospital Hong Kong, Hong Kong[55]The Chinese University of Hong Kong Shatin, Hong Kong[56]A.S.L. Napoli 1 Centro Ospedale del Mare Ponticelli, Napoli, Italy, 80147[57]Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS Bologna, Italy, 40138[58]Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Brescia, Italy, 25123[59]Azienda Ospedaliero-Universitaria Cagliari, Italy, 09124[60]Azienda Ospedaliera Universitaria Careggi Firenze, Italy, 50134[61]Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122[62]Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168[63]Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) Verona, Italy, 37134[64]Seoul National University Bundang Hospital Gyeonggi-do Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620[65]The Catholic University of Korea, St. Vincent's Hospital Suwon-si, Gyeonggi-do, Korea, Republic of, 16247[66]Ajou University Hospital Suwon, Gyeonggi-do, Korea, Republic of, 16499[67]Dong-A University Hospital Busan, Korea, Republic of, 602715[68]Korea University Anam Hospital Seoul, Korea, Republic of, 02481[69]Severance Hospital, Yonsei University Health System Seoul, Korea, Republic of, 03722[70]Asan Medical Center Seoul, Korea, Republic of, 05505[71]Samsung Medical Center Seoul, Korea, Republic of, 06351[72]Centrum Medyczne Pratia Gdynia Gdynia, Poland, 81338[73]Centrum Onkologii-Instytut im.M.Sklodowskiej Curie Gliwice, Poland, 44101[74]Pratia MCM Krakow Krakow, Poland, 30510[75]Przychodnia Med-Polonia Sp. z o.o. Poznan, Poland, 60693[76]Wielkopolskie Centrum Onkologii Poznan, Poland, 61866[77]Centrum Zdrowia MDM Warszawa, Poland, 00635[78]Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy Warszawa, Poland, 02034[79]NZOZ Centrum Badan Klinicznych Wroclaw, Poland, 51162[80]SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" Arkhangelsk, Russian Federation, 164045[81]SBHI Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine Chelyabinsk, Russian Federation, 454087[82]Irkutsk Regional Oncology Dispensary Irkutsk, Russian Federation, 664035[83]SBIH " Clinical Oncological Dispensary # 1" Krasnodar, Russian Federation, 350040[84]RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee Kursk, Russian Federation, 305035[85]"VitaMed" LLC Moscow, Russian Federation, 121309[86]SBIH of Moscow city "Moscow city oncology hospital №62" of Moscow Healthcare departement Moscow, Russian Federation, 143423[87]CJSC Avicenna Novosibirsk, Russian Federation, 630099[88]BHI of Omsk region "Clinical Oncology Dispensary" Omsk, Russian Federation, 644013[89]Pavlov First Saint Petersburg State Medical University Saint-Petersburg, Russian Federation, 197022[90]SPb SBIH "City Clinical Oncological Dispensary" Saint-Petersburg, Russian Federation, 197022[91]FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" Saint-Petersburg, Russian Federation, 197758[92]SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan Ufa, Russian Federation, 450054[93]Hospital Universitario Reina Sofia Cordoba, Córdoba, Spain, 14004[94]Hospital Universitario Ramon y Cajal Madrid, Spain, 28034[95]Hospital Universitario Clinico San Carlos Madrid, Spain, 28040[96]Hospital Universitario 12 de Octubre Madrid, Spain, 28041[97]Hospital Universitario La Paz Madrid, Spain, 28046[98]Hospital Universitario HM Madrid Sanchinarro Madrid, Spain, 28050[99]Hospital Universitari i Politecnic La Fe Valencia, Spain, 46026[100]Changhua Christian Medical Foundation Changhua Christian Hospital Changhua, Taiwan, 500006[101]Chang Gung Memorial Hospital, Chiayi Chiayi City, Taiwan, 613[102]E-DA Cancer Hospital Kaohsiung, Taiwan, 82445[103]Kaohsiung Chang Gung Memorial Hospital Kaohsiung, Taiwan, 833[104]National Cheng Kung University Hospital Tainan, Taiwan, 704[105]National Taiwan University Hospital Taipei, Taiwan, 100[106]Taipei Veterans General Hospital Taipei, Taiwan, 11217[107]Chang Gung Memorial Hospital, Linkou Taoyuan, Taiwan, 333[108]Baskent University Adana Application and Research Center Adana, Turkey, 01229[109]Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital Ankara, Turkey, 06105[110]Ankara City Hospital Ankara, Turkey, 06800[111]Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Istanbul, Turkey, 34098[112]Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital Istanbul, Turkey, 34147[113]Inonu Uni. Med. Fac. Malatya, Turkey, 44280[114]CNE"City Clin Hosp#4"of Dnipro City Council Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU Dnipro, Ukraine, 49102[115]Communal Non-profit Enterprise Regional Center of Oncology Kharkiv, Ukraine, 61070[116]CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection Kharkiv, Ukraine, 61166[117]Medical Center of Limited Liability Company Medical Center Concilium Medical Kyiv, Ukraine, 04050[118]Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council Lutsk, Ukraine, 43018[119]Communal Institution Odesa Regional Clinical Hospital Odesa, Ukraine, 65025[120]CNCE of SRC Sumy Reg Clinical Oncology Dispensary, SSU, Chair of Oncology and Radiology Sumy, Ukraine, 40022[121]Zaporizhzhya City Clinical Hospital #3 Zaporizhzhia, Ukraine, 69032[122]Beverly Hills Cancer Center Beverly Hills, California, United States, 90211
研究目的:
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.