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.