摘要内科肿瘤学是以药物治疗为特征的学科，不断研发高效、低不良反应的抗肿瘤新药是发展肿瘤内科治疗的前提。临床试验是新药从研发到应用不可或缺的重要环节，决定着药物研发的成败。中国抗肿瘤新药临床试验开始于1960年，2008年以来发展迅速。在国家政策引导和激励下，社会各界共同参与，中国抗肿瘤新药研发已经从仿制向原始创新转变。中国自主研发的抗肿瘤新药得到国际上的广泛认可，越来越多的国产抗肿瘤新药上市，造福了中国恶性肿瘤患者。文章回顾了1960—2020年中国抗肿瘤新药临床试验的发展历程以及60年间取得的主要成果。深入了解历史将有助于我们在实施"健康中国"战略时牢记使命、掌握方向，取得更大成果。

abstractsMedical oncology is a subject characterized by drug therapy. Continuous research and development (R&D) of high-efficiency and low-toxic anti-cancer drugs is the premise of the development of medical oncology. Clinical trials play an indispensable role in the process from drug R&D to application, which determines the success or failure of a new drug. The clinical trials for anti-cancer investigational new drug (IND) in China began in 1960, and have developed rapidly since 2008. With the guidance and support of national policies, as well as involved by all aspects of the society, the R&D of anti-cancer drugs in China has changed from imitation to innovation. China innovative anti-cancer drugs have been widely recognized in the world, and more and more new domestic anti-cancer drugs have been used in clinical practice, bringing benefit to Chinese cancer patients. This article reviews the development of the clinical trials for anti-cancer IND in China from 1960 to 2020, and the main achievements having been made in the past 60 years. A thorough understanding of this history will help us keep in mind the mission and grasp the direction, as to make more achievements when implementing the strategy of "Healthy China" .