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Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

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研究单位: [1]Amgen [2]Zai Lab (China only) [3]Alaska Oncology and Hematology LLC,Anchorage,Alaska,United States,99508 [4]Mayo Clinic Arizona,Phoenix,Arizona,United States,85054 [5]The Oncology Institute Clinical Research,Cerritos,California,United States,90703 [6]University of California Los Angeles,Los Angeles,California,United States,90095 [7]Mayo Clinic Florida,Jacksonville,Florida,United States,32224 [8]Saint Francis Medical Group,Indianapolis,Indiana,United States,46237 [9]University of Michigan,Ann Arbor,Michigan,United States,48109 [10]Mayo Clinic Rochester,Rochester,Minnesota,United States,55905 [11]Healthier Hematology and Oncology Excelsior Integrated Medical Group,Brooklyn,New York,United States,11220 [12]White Plains Hospital Medical Center,White Plains,New York,United States,10604 [13]Levine Cancer Institute University,Charlotte,North Carolina,United States,28204 [14]FirstHealth Cancer Center,Pinehurst,North Carolina,United States,28374 [15]Avera Cancer Institute,Sioux Falls,South Dakota,United States,57108 [16]Vanderbilt University Medical Center,Nashville,Tennessee,United States,37232 [17]Inova Schar Cancer Institute,Fairfax,Virginia,United States,22031 [18]Medical Oncology Associates, PS,Spokane,Washington,United States,99208 [19]Instituto Alexander Fleming,Caba,Buenos Aires,Argentina,C1426ANZ [20]Hospital Universitario Fundacion Favaloro,Ciudad Autonoma de Buenos Aires,Buenos Aires,Argentina,C1093AAS [21]Sociedad de Beneficencia Hospital Italiano,Cordoba,Córdoba,Argentina,5000 [22]Hospital Privado Universitario de Cordoba,Cordoba,Córdoba,Argentina,X5016KEH [23]Hospital Provincial del Centenario,Rosario,Santa Fe,Argentina,S2002KDS [24]Exelsus Oncologia Clinica,San Miguel de Tucuman,Tucuman,Argentina,4000 [25]Instituto Argentino de Diagnostico y Tratamiento IADT,Buenos Aires,Argentina,C1122AAL [26]Hospital Britanico de Buenos Aires,Buenos Aires,Argentina,C1280AEB [27]Liverpool Hospital,Liverpool,New South Wales,Australia,2170 [28]St John of God Murdoch Hospital,Murdoch,Western Australia,Australia,6150 [29]Universitair Ziekenhuis Antwerpen,Edegem,Belgium,2650 [30]Universitair Ziekenhuis Gent,Gent,Belgium,9000 [31]Universitair Ziekenhuis Leuven - Campus Gasthuisberg,Leuven,Belgium,3000 [32]Centre Hospitalier Universitaire de Liege - Sart Tilman,Liege,Belgium,4000 [33]Núcleo de Oncologia da Bahia,Salvador,Bahia,Brazil,40170-110 [34]Centro de Oncologia Mackenzie,Curitiba,Paraná,Brazil,80440-220 [35]Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda,Ijui,Rio Grande Do Sul,Brazil,98700-000 [36]Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul,Porto Alegre,Rio Grande Do Sul,Brazil,90610-000 [37]Clinica de Oncologia Reichow,Blumenau,Santa Catarina,Brazil,89010-340 [38]Centro de Pesquisa e Ensino em Oncologia de Santa Catarina,Florianopolis,Santa Catarina,Brazil,88020-210 [39]Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas,Santo Andre,São Paulo,Brazil,09060-650 [40]Instituto Nacional de Cancer,Rio de Janeiro,Brazil,20231-050 [41]Hospital Nove de Julho - dasa,São Paulo,Brazil,01409-001 [42]Instituto Brasileiro de Controle do Cancer Ibcc,São Paulo,Brazil,04014-002 [43]Multiprofile Hospital for Active Treatment Park Hospital EOOD,Branipole Village,Bulgaria,4109 [44]Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD,Haskovo,Bulgaria,6300 [45]University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD,Pleven,Bulgaria,5800 [46]University Multiprofile Hospital for Active Treatment Pulmed OOD,Plovdiv,Bulgaria,4002 [47]Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD,Sofia,Bulgaria,1407 [48]Multiprofile Hospital for Active Treatment Serdika EOOD,Sofia,Bulgaria,1632 [49]Cross Cancer Institute,Edmonton,Alberta,Canada,T6G 1Z2 [50]The Ottawa Hospital Cancer Centre,Ottawa,Ontario,Canada,K1H 8L6 [51]Sunnybrook Research Institute Sunnybrook Health Sciences Centre,Toronto,Ontario,Canada,M4N 3M5 [52]Jewish General Hospital,Montreal,Quebec,Canada,H3T 1E2 [53]James Lind Centro de Investigacion del Cancer,Temuco,Cautín,Chile,4800827 [54]Clinica CIDO,Temuco,Cautín,Chile,4810218 [55]Centro de Estudios Clinicos SAGA Spa,Santiago,Chile,7500653 [56]Centro de Estudios Clinicos e Investigaciones Medicas CeCim,Santiago,Chile,8320000 [57]The First Affiliated Hospital of Bengbu Medical College,Bengbu,Anhui,China,233099 [58]The First Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China,230022 [59]Anhui Provincial Cancer Hospital,Hefei,Anhui,China,230031 [60]Cancer Hospital of Chinese Academy of Medical Sciences,Beijing,Beijing,China,100021 [61]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences,Beijing,Beijing,China,100032 [62]Chongqing University Three Gorges Hospital,Chongqing,Chongqing,China,400037 [63]Fujian Medical University Union Hospital,Fuzhou,Fujian,China,350001 [64]Fujian Cancer Hospital,Fuzhou,Fujian,China,350014 [65]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China,361003 [66]Lanzhou University Second Hospital,Lanzhou,Gansu,China,730030 [67]Gansu Wuwei Tumour Hospital,Wuwei,Gansu,China,733000 [68]Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China,510030 [69]Guangdong Provincial Peoples Hospital,Guangzhou,Guangdong,China,510180 [70]Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China,510700 [71]Cancer Hospital of Shantou University Medical College,Shantou,Guangdong,China,515031 [72]The First Affiliated Hospital of Hainan Medical University,Haikou,Hainan,China,570102 [73]Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050011 [74]Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology,Wuhan,Hebei,China,430030 [75]Harbin Medical University Cancer Hospital,Harbin,Heilongjiang,China,150000 [76]Anyang Cancer Hospital,Anyang,Henan,China,455001 [77]The First Affiliated Hospital of Henan University of science and Technology,Luoyang,Henan,China,471000 [78]Henan Cancer Hospital,Zhengzhou,Henan,China,450000 [79]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450052 [80]Taihe Hospital Affiliated Hospital of Hubei University of Medicine,Shiyan,Hubei,China,442000 [81]Hubei Cancer Hospital,Wuhan City,Hubei,China,430079 [82]The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech,Wuhan,Hubei,China,430000 [83]Xiangya Hospital of Central South University,Changsha,Hunan,China,410000 [84]Hunan Cancer Hospital,Changsha,Hunan,China,410006 [85]Nanjing First Hospital,Nanjing,Jiangsu,China,210006 [86]The Second Affiliated Hospital of Soochow University,Suzhou,Jiangsu,China,215004 [87]Affiliated Hospital of Jiangnan University,Wuxi,Jiangsu,China,214122 [88]The Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu,China,221002 [89]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China,330000 [90]The First Hospital of Jilin University,Changchun,Jilin,China,130021 [91]China-Japan Union Hospital of Jilin University,Changchun,Jilin,China,130022 [92]The First Affiliated Hospital of Jinzhou Medical University,Jinzhou,Liaoning,China,121000 [93]The First Hospital of China Medical University,Shenyang,Liaoning,China,110001 [94]Liaoning Cancer Hospital,Shenyang,Liaoning,China,110042 [95]The First Affiliated Hospital of Xi an Jiaotong University,XI An,Shaanxi,China,710061 [96]Jinan Central Hospital,Jinan,Shandong,China,250013 [97]The Affiliated Cancer Hospital of Shandong First Medical University,Jinan,Shandong,China,250117 [98]The Affiliated Hospital of Qingdao University,Qingdao,Shandong,China,266000 [99]Fudan University Shanghai Cancer Center,Shanghai,Shanghai,China,200032 [100]Zhongshan Hospital Fudan University,Shanghai,Shanghai,China,200032 [101]Shanghai General Hospital,Shanghai,Shanghai,China,200080 [102]Shanghai East Hospital,Shanghai,Shanghai,China,200123 [103]Ruijin Hospital Shanghai Jiao Tong University School of Medicine,Shanghai,Shanghai,China,201800 [104]Changzhi Peoples Hospital,Changzhi,Shanxi,China,046000 [105]Linfen Central Hospital,Linfen,Shanxi,China,100032 [106]Shanxi Province Cancer Hospital,Taiyuan,Shanxi,China,030013 [107]Sichuan Cancer Hospital,Chengdu,Sichuan,China,610041 [108]The First Affiliated Hospital Zhejiang University School of Medicine,Hangzhou,Zhejiang,China,310003 [109]The Second Affiliated Hospital Zhejiang University School of Medicine,Hangzhou,Zhejiang,China,310009 [110]Sir Run Run Shaw Hospital Zhejiang University School of Medicine,Hangzhou,Zhejiang,China,310016 [111]Taizhou Hospital of Zhejiang Province,Linhai,Zhejiang,China,317000

关键词: Gastric Cancer Gastroesophageal Junction Adenocarcinoma Bemarituzumab FGFR2b Overexpression

研究目的:
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)

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