Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
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研究单位：[1]Merck Sharp & Dohme LLC[2]( Site 0116) Wenatchee, Washington, United States, 98801[3]UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128) Orange, California, United States, 92868[4]University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113) Miami, Florida, United States, 33136[5]Greater Baltimore Medical Center ( Site 0102) Baltimore, Maryland, United States, 21204[6]Minnesota Oncology Hematology, PA ( Site 8000) Minneapolis, Minnesota, United States, 55404[7]University of Rochester ( Site 0122) Rochester, New York, United States, 14642[8]Cancer Treatment Centers of America - Philadelphia ( Site 0112) Philadelphia, Pennsylvania, United States, 19124[9]Allegheny General Hospital ( Site 0118) Pittsburgh, Pennsylvania, United States, 15212[10]Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001) Roanoke, Virginia, United States, 24014[11]Instituto Medico Alexander Fleming ( Site 0307) Buenos Aires, Caba, Argentina, C1426ANZ[12]Instituto de Investigaciones Metabolicas ( Site 0312) Buenos Aires, Argentina, C1012AAR[13]Fundacion Favaloro - Hospital Universitario ( Site 0302) Buenos Aires, Argentina, C1093AAS[14]Centro Oncologico Riojano Integral ( Site 0313) La Rioja, Argentina, F5300COE[15]Instituto San Marcos ( Site 0311) San Juan, Argentina, J5400EBB[16]Liverpool Hospital ( Site 2301) Liverpool, New South Wales, Australia, 2170[17]Southern Medical Day Care Centre ( Site 2303) Wollongong, New South Wales, Australia, 2500[18]Box Hill Hospital ( Site 2300) Box Hill, Victoria, Australia, 3128[19]Instituto do Cancer do Ceara ( Site 0407) Fortaleza, Ceara, Brazil, 60430-230[20]CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405) Curitiba, Parana, Brazil, 80810-050[21]Hospital de Caridade de Ijui ( Site 0402) Ijui, Rio Grande Do Sul, Brazil, 98700 000[22]Hospital Nossa Senhora da Conceicao ( Site 0403) Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200[23]CEPON - Centro de Pesquisas Oncologicas ( Site 0400) Florianopolis, Santa Catarina, Brazil, 88034-000[24]Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401) Rio de Janeiro, Brazil, 20231-050[25]IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404) Sao Paulo, Brazil, 03102-002[26]BC Cancer - Abbotsford ( Site 0206) Abbotsford, British Columbia, Canada, V2S 0C2[27]Sunnybrook Research Institute ( Site 0202) Toronto, Ontario, Canada, M4N 3M5[28]Princess Margaret Cancer Centre ( Site 0203) Toronto, Ontario, Canada, M5G 2M9[29]McGill University Health Centre ( Site 0208) Montreal, Quebec, Canada, H4A 3J1[30]Instituto Clinico Oncologico del Sur ( Site 0500) Temuco, Araucania, Chile, 4810469[31]Fundacion Arturo Lopez Perez FALP ( Site 0501) Santiago, Region M. De Santiago, Chile, 7500921[32]Sociedad Oncovida S.A. ( Site 0508) Santiago, Region M. De Santiago, Chile, 7510032[33]Pontificia Universidad Catolica de Chile ( Site 0502) Santiago, Region M. De Santiago, Chile, 7620002[34]Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421) Beijing, Beijing, China, 100021[35]Peking Union Medical College Hospital ( Site 2425) Beijing, Beijing, China, 100730[36]Fujian Medical University Union Hospital ( Site 2410) Fuzhou, Fujian, China, 350001[37]Fujian Provincial Cancer Hospital ( Site 2414) Fuzhou, Fujian, China, 350014[38]900 Hospital of the Joint ( Site 2418) Fuzhou, Fujian, China, 350025[39]The First Affiliated Hospital of Xiamen University ( Site 2430) Xiamen, Fujian, China, 361003[40]Zhongshan Hospital Xiamen University ( Site 2447) Xiamen, Fujian, China, 361004[41]Guangdong General Hospital ( Site 2431) Guangzhou, Guangdong, China, 510080[42]Peking University Shenzhen Hospital ( Site 2442) Shenzhen, Guangdong, China, 518036[43]Fourth Hospital Of Hebei Medical University ( Site 2436) Shijiazhuang, Hebei, China, 050011河北医科大学第四医院[44]Harbin Medical University Cancer Hospital ( Site 2401) Harbin, Heilongjiang, China, 150081
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.
The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).
