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A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

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研究单位: [1]Akeso [2]Fudan University [3]Cancer Hospital of The University of Chinese Academy of Sciences [4]Memorial Sloan Kettering Cancer Center [5]City of Hope,Duarte,California,United States,91010 [6]University of Michigan,Ann Arbor,Michigan,United States,48109 [7]Icahn School of Medicine at Mount Sinai,New York,New York,United States,10029 [8]Memorial Sloan Kettering Cancer Center,New York,New York,United States,10065 [9]Blacktown Hospital,Blacktown,New South Wales,Australia,2148 [10]Chris O'Brien Lifehouse,Camperdown,New South Wales,Australia [11]St Vincent''s Public Hospital Sydney,Darlinghurst,New South Wales,Australia,2010 [12]Genesis Care North Shore,St Leonards,New South Wales,Australia,2065 [13]The First Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China,230022 [14]Fujian Cancer Hospital,Fuzhou,Fujian,China,350014 [15]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China,361003 [16]Dongguan People''s Hospital,Dongguan,Guangdong,China,523058 [17]The First Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong,China,510080 [18]Affiliated Cancer Hospital and Institute of Guangzhou Medical University,Guangzhou,Guangdong,China,510095 [19]Sun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510120 [20]The First Affiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong,China,510120 [21]Zhujiang Hospital of Southern Medical University,Guangzhou,Guangdong,China,510260 [22]Nanfang Hospital, Southern Medical University,Guangzhou,Guangdong,China,510515 [23]The Sixth Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong,China,510655 [24]The First Affiliated Hospital of Guangdong Pharmaceutical University,Guangzhou,Guangdong,China,510699 [25]Guangzhou Panyu Central Hospital,Guangzhou,Guangdong,China,511400 [26]Jiangmen Central Hospital,Jiangmen,Guangdong,China,529000 [27]Cancer Hospital of Shantou University Medical College,Shantou,Guangdong,China,515041 [28]Shenzhen People''s Hospital,Shenzhen,Guangdong,China,518020 [29]Affiliated Hospital of Guangdong Medical University,Zhanjiang,Guangdong,China,524000 [30]The Fifth Affiliated Hospital of Sun Yat-sen University,Zhuhai,Guangdong,China,519000 [31]Affiliated Hospital of Guilin Medical University,Guilin,Guangxi,China,541001 [32]The People''s Hospital of Guangxi Zhuang Autonomous Region,Nanning,Guangxi,China,530016 [33]Guangxi Medical University Cancer Hospital,Nanning,Guangxi,China,530021 [34]The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China,530021 [35]Guizhou Cancer Hospital,Guiyang,Guizhou,China,550000 [36]The First Affiliated Hospital of Hainan Medical University,Haikou,Hainan,China,570102 [37]Hainan General Hospital,Haikou,Hainan,China,570311 [38]Hubei Cancer Hospital,Wuhan,Hubei,China,430079 [39]The Second Xiangya Hospital of Central South University,Changsha,Hunan,China,410012 [40]Hunan Cancer Hospital,Changsha,Hunan,China,410031 [41]The First Affiliated Hospital of University of South China,Hengyang,Hunan,China,421001 [42]The Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China,330002 [43]Jiangxi Cancer Hospital,Nanchang,Jiangxi,China,330029 [44]Fudan University Shanghai Cancer Center,Shanghai,Shanghai,China,200032 [45]Sichuan Cancer Hospital,Chengdu,Sichuan,China,610042 [46]The Affiliated Hospital of Southwest Medical University,Luzhou,Sichuan,China,646000 [47]Yunnan Cancer Hospital,Kunming,Yunnan,China,650118 [48]Zhejiang Cancer Hospital,Hangzhou,Zhejiang,China,310005 [49]Taizhou Hospital of Zhejiang Province,Taizhou,Zhejiang,China,317099

研究目的:
This study is a randomized, double-blind, multi-center phase III clinical study to compare the efficacy and safety of penpulimab combined with chemotherapy and placebo combined with chemotherapy in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

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