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Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study

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研究单位： [1]Merck Sharp & Dohme LLC [2]Wuhan Tongji Hospital ( Site 0724) Wuhan, Hubei, China, 430030 [3]Anhui Provincial Hospital ( Site 0708) Hefei, Anhui, China, 230001 [4]he First Affiliated Hospital of Anhui Medical University ( Site 0707) Hefei, Anhui, China, 230022 [5]Harbin Medical University Cancer Hospital ( Site 0714) Harbin, Heilongjiang, China, 150081 [6]Hunan Cancer Hospital ( Site 0722) Changsha, Hunan, China, 410013 [7]Jiangsu Cancer Hospital (Site 0704) Nanjing, Jiangsu, China, 210000 [8]PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0706) Nanjing, Jiangsu, China, 210002 [9]The First Hospital Of Jilin University ( Site 0719) Chang chun, Jilin, China, 130021 [10]Jilin Cancer Hospital ( Site 0718) Changchun, Jilin, China, 130012 [11]Zhejiang Cancer Hospital ( Site 0726) Hangzhou, Zhejiang, China, 310022 [12]Beijing Cancer Hospital ( Site 0700) Beijing, China, 100042 [13]Chinese PLA General Hospital (Site 0703) Beijing, China, 100042 [14]Peking Union Medical College Hospital ( Site 0712) Beijing, China, 100730 [15]Fujian Medical University Union Hospital ( Site 0721) Fuzhou, China, 350001 [16]Fujian Province Cancer Hospital ( ( Site 0717) Fuzhou, China, 350014 [17]The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0705) Hangzhou, China, 310009 [18]Sir Sun Sun Shaw Hosp, Zhejiang Univ,Oncology dept. ( Site 0720) Hangzhou, China, 310016 [19]The Affiliated Hospital of Qingdao University ( Site 0709) Qingdao, China, 266003 [20]Ruijin Hospital, Shanghai Jiaotong University ( Site 0701) Shanghai, China, 200025 [21]Shanghai Chest Hospital ( Site 0727) Shanghai, China, 200030 [22]Fudan University Shanghai Cancer Center ( Site 0723) Shanghai, China, 200032 [23]Zhongshan Hospital affiliated to Fudan University ( Site 0715) Shanghai, China, 200032 [24]Henan Cancer Hospital ( Site 0725) Zhengzhou, China, 450008

关键词： Programmed Cell Death-1 (PD1 PD-1) Programmed Death-Ligand 1 (PDL1 PD-L1) Programmed Death-Ligand 2 (PDL2 PD-L2) Gene expression profiling (GEP)

研究目的：

In the China extension study, Chinese participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that has progressed after first-line standard therapy will be randomized to receive either single agent pembrolizumab or the Investigator's choice of chemotherapy with paclitaxel, docetaxel, or irinotecan. The primary extension study hypothesis is that treatment with pembrolizumab will prolong overall survival (OS) as compared to treatment with chemotherapy.