晚期结直肠癌新药临床试验设计及审评考虑

Clinical trial design and evaluation consideration of new drugs for advanced colorectal cancer

摘要: 结直肠癌（colorectal cancer，CRC）是中国恶性肿瘤发病率和死亡率均较高的肿瘤，改善患者生存状态是其重要的治疗目标。伴随新药研发进展，晚期CRC患者的总生存期不断延长，因此对临床试验设计和终点选择带来了挑战。本文将从审评角度，通过对目前晚期CRC中抗肿瘤药物的研发进展、生物标志物的研发以及临床研究设计的情况进行分析，阐述当前对晚期CRC临床试验设计与审评考虑，期望为抗肿瘤药物研发人员在晚期CRC临床试验设计和终点选择方面提供参考，提高研发效率，使患者早日获益。

Abstract: Colorectal cancer (CRC) has a relatively high incidence in China and is associated with a high mortality rate. Therefore, improving survival is an important therapeutic goal. With the development of new drugs, the overall survival of patients with advanced CRC is increasing. This poses a challenge to the design and endpoint selection of clinical trials. To promote research and development and provide a reference for antitumor drug researchers in China, this study discusses the design and related review evaluation of clinical trial designs for new CRC drugs. We also examine the research and development progress of antitumor drugs, biomarkers, and clinical research design for advanced CRC.