Wang Yan-Bo, Lv Gang, Xu Feng-Hua, Ma Lin-Lu, Yao Yong-Ming
Department of Microbiology and Immunology, Trauma Research Center, Fourth Medical Center of the Chinese PLA General Hospital, Beijing, China.
Department of General Surgery, The 8th Medical Centre of Chinese PLA General Hospital, Beijing, China.
Front Pharmacol. 2020 Jan 10;10:1539. doi: 10.3389/fphar.2019.01539. eCollection 2019.
Comprehensively evaluate the immunotherapeutic clinical trials and provide reference for melanoma treatment and research. The website of was searched to retrieve and download all registered clinical trials for melanoma immunotherapy on August 1 (updated on August 25), 2019. All registration trials met the inclusion criteria were collected regardless of the type of study, the status of recruitment, and the results of the study. The general characteristics, methodological characteristics, and the types of immunotherapeutic drugs included of these trials were analyzed. Finally, 242 eligible trials were included and evaluated. Of them, 30.6% were completed, 16.9% were terminated, and two were withdrawn; 77.7% recruited less than 100 participants; 30.5% were randomized; 45.5% was single group assignment; 88.8% were not masked; the primary purpose was treatment; 44.2% had data on monitoring committees; 27.7% used US FDA-regulated immunization drugs; 78.5% without results posted; 43.0% were sponsored by the industry. Immunological checkpoint inhibitors were most often studied, with 53.6% of the trials involving PD-1, the most commonly studied was Nivolumab. Currently, most of the registered clinical trials for melanoma immunotherapy were interventional open-label trials. Most immunotherapy research hotspots were in the FDA-regulated drug product, and a few trials reported available test results. It is necessary to strengthen the supervision of results and explore and disseminate more effective and safe immunotherapy methods.
全面评估免疫治疗临床试验，为黑色素瘤的治疗和研究提供参考。检索并下载了截至2019年8月1日（8月25日更新）在该网站上注册的所有黑色素瘤免疫治疗临床试验。收集所有符合纳入标准的注册试验，无论研究类型、招募状态和研究结果如何。分析了这些试验的一般特征、方法学特征以及所包含的免疫治疗药物类型。最后，纳入并评估了242项符合条件的试验。其中，30.6%已完成，16.9%已终止，两项已撤回；77.7%招募的参与者少于100人；30.5%为随机试验；45.5%为单组试验；88.8%未设盲；主要目的是治疗；44.2%有监测委员会的数据；27.7%使用美国食品药品监督管理局（US FDA）监管的免疫药物；78.5%未公布结果；43.0%由行业赞助。免疫检查点抑制剂是研究最多的，53.6%的试验涉及PD-1，最常研究的是纳武单抗。目前，大多数注册的黑色素瘤免疫治疗临床试验是介入性开放标签试验。大多数免疫治疗研究热点集中在美国食品药品监督管理局监管的药品中，少数试验报告了可用的测试结果。有必要加强对结果的监管，探索并推广更有效、安全的免疫治疗方法。
