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目的:探讨2000—2019年胃癌随机对照试验（RCT）研究的开展现状和已发表RCT研究的基本特征。方法:在ClinicalTrials.gov网站搜索2000年1月至2019年12月期间注册的以“胃癌”为关键词的三期或四期RCT研究，记录其基本特征。搜索PubMed和Scopus数据库以确定计划在2016年6月前结束的RCT研究的最终发表状态。使用《医学科研论文撰写的基本要求》评估已发表RCT研究的报告充分性。根据存在的偏倚和（或）系统综述的引用情况，评估是否存在可避免的设计局限采用χn 2检验或Fisher确切概率法对数据进行分析。n 结果:共纳入262项RCT研究，呈逐年上升趋势（从2000年的1项升至2015年的30项）。干预措施为靶向治疗或免疫治疗的RCT研究占比从2000—2004年的0升至2015—2019年的37.1%（36/97）。亚洲地区注册的RCT研究为191项，非亚洲地区为71项；非亚洲地区多中心RCT研究的比例高于亚洲地区［70.4%（50/71）比50.3%（96/191），χ2=8.527，n P=0.003］。分析137项RCT研究的成果发表状态，81项（59.1%）已发表；其中65项（80.2%）判定为报告充分，63项（77.8%）判定为存在可避免的设计缺陷。n 结论:靶向和免疫治疗相关RCT研究正在成为胃癌研究热点。目前亚洲地区开展的多中心临床研究较少，已开展RCT研究的成果发表比例较低。已发表的RCT研究中相当一部分报告不充分，存在可避免的设计缺陷。“,”Objectives:To analyze the current development status of gastric cancer (GC) randomized controlled trials (RCT) between 2000 and 2019, and to review the basic characteristics of published RCT.Methods:ClinicalTrials.gov was searched for phase 3 or 4 RCT conducted between January 2000 and December 2019 with the keyword “gastric cancer”, and the development trend of different types of RCT during different time periods was described. Basic features of registered RCT such as intervention, study area, single-center or multicenter, sample size, and funding were presented. PubMed and Scopus databases were searched to judge the publication status of studies completed until June 2016. The adequacy of the report was estimated by the Consolidated Standards of Reporting Trials (CONSORT) checklist. Design flaws were evaluated by Cochrane tool and/or whether a systematic literature review was cited. The data was analyzed by χn 2 test or Fisher exact test.n Results:There were 262 RCT including in the present study. The number of GC-RCT registered on ClinicalTrials.gov had been on the rise from 1 case in 2000 to 30 cases in 2015. The proportion of RCT associated with targeted therapy or immunotherapy increased from 0 during 2000—2004 to 37.1% (36/97) during2015—2019. The RCT registered in Asia was 191 cases, while that in non-Asia region was 71 cases. The proportion of multi-center RCT from non-Asia was higher than that from Asia (70.4% (50/71) n vs. 50.3% (96/191), χ2=8.527, n P=0.003). The proportion of RCT published was 59.1% (81/137). Among the published RCT, 65 (80.2%) studies were reported adequately, but 63 (77.8%) studies had avoidable design limitations.n Conclusions:Targeted therapy and immunotherapy have become research hotspots in the treatment of GC. At present, there are inadequate multicenter RCT in Asia, and the publication rate of RCT is low. A considerable number of published RCT are reported inadequately and have avoidable design flaws.