摘要
目的总结中国食管鳞状细胞癌(鳞癌)药物临床试验进展和趋势。方法基于国家药品监督管理局药物临床试验登记与信息公示平台和药品数据查询系统,分析2012—2021年中国食管鳞癌药物临床试验特征、试验用药品特征和上市药品情况。结果2012—2021年我国共开展了49项食管鳞癌临床试验,占全部肿瘤治疗药物临床试验的1.6%,其中由国内企业发起39项(79.6%);辅助和新辅助试验有6项(12.2%),局部治疗试验9项(18.4%);全球与国内企业发起的试验在治疗线数分布上存在差异(P=0.032)。上述试验涉及29种药品,其中靶向药物23种(79.3%),靶向程序性死亡受体1、程序性死亡受体配体1和表皮生长因子受体的药物数量最多。2012—2021年我国有2种食管鳞癌药物上市,均获批一线治疗和二线治疗适应证。结论我国食管鳞癌药物临床开发取得了巨大成果,建议国内企业加大食管鳞癌投入,关注辅助治疗和局部治疗适应证,挖掘更多新靶点和药物类别,注重关键注册研究设计细节。
Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China.Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration,the characteristics of clinical trials,investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed.Results From 2012 to 2021,a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China,accounting for 1.6%of all clinical trials of anticancer drugs.Among them,there were 39(79.6%)trials initiated by domestic pharmaceutical enterprises,6(12.2%)for adjuvant and neoadjuvant treatment,and 9(18.4%)for local treatment.There were differences in the treatment line distribution between global and domestic enterprise-initiated trials(P=0.032).The above trials covered 29 investigational drugs,including 23(79.3%)targeted drugs,most of which targeted programmed death-1,programmed death-ligand 1 and epidermal growth factor receptor.From 2012 to 2021,there were 2 drugs for esophageal squamous cell carcinoma listed in China,both of which were approved for the first-line and second-line treatment.Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China.It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma,pay attention to adjuvant and local treatment,explore novel targets and drug categories,and focus on the details of pivotal trials.
作者
吴大维
黄慧瑶
祝琦
俞悦
李紫薇
孟鑫雨
杜静婷
尕曼
苗双曼
邢淑君
唐玉
李宁
WU Dawei;HUANG Huiyao;ZHU Qi;YU Yue;LI Ziwei;MENG Xinyu;DU Jingting;GA Man;MIAO Shuangman;XING Shujun;TANG Yu;LI Ning(Clinical Trials Center,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,100021,P.R.China;Department of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing,211198,P.R.China;University of Melbourne,Faculty of Medicine,Dentistry and Health Sciences,Melbourne,3010,Australia)
出处
《中国胸心血管外科临床杂志》
CSCD
北大核心
2022年第12期1601-1606,共6页
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
基金
中国医学科学院医学与健康科技创新工程(2021-I2M-1-045)。
关键词
食管肿瘤
鳞状细胞癌
中国
药物
临床试验
Esophageal neoplasms
squamous cell carcinoma
China
drug
clinical trial
