Dan Lv,1 Yuling Liu,1 Ruying Tang,1 Sai Fu,1 Shasha Kong,1 Qian Liao,1 Hui Li,1,2 Longfei Lin1 

1Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, 100700, People’s Republic of China; 2Institute of Traditional Chinese Medicine Health Industry, China Academy of Chinese Medical Sciences, Jiangxi, 330006, People’s Republic of China

Correspondence: Hui Li; Longfei Lin, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Nanxiaojie 16, 8 Dongzhimennei Ave, Beijing, 100700, People’s Republic of China, Tel +86-10-64032658, Email hli1967@icmm.ac; lflin@icmm.ac.cn

Abstract: The potential anti-cancer effect of traditional Chinese medicine (TCM) monomers has been widely studied due to their advantages of well-defined structure, clear therapeutic effects, and easy quality control during the manufacturing process. However, clinical trial information on these monomers is scarce, resulting in a lack of knowledge regarding the research progress, efficacy, and adverse reactions at the clinical stage. Therefore, this study systematically reviewed the clinical trials on the anti-cancer effect of TCM monomers registered in the Clinicaltrials.gov website before 2023.4.30, paying special attention to the trials on tumors, aiming to explore the research results and development prospects in this field. A total of 1982 trials were started using 69 of the 131 TCM monomers. The number of clinical trials performed each year showed an overall upward trend. However, only 26 monomers entered into 519 interventional anti-tumor trials, with vinblastine (194, 37.38%) and camptothecin (146, 28.13%) being the most used. A total of 45 tumors were studied in these 519 trials, with lymphoma (112, 21.58%) being the most frequently studied. Clinical trials are also unevenly distributed across locations and sponsors/collaborators. The location and the sponsor/collaborator with the highest number of performed trials were the United States (651,32.85%) and NIH (77). Therefore, China and its institutions still have large room for progress in promoting TCM monomers in anti-tumor clinical trials. In the next step, priority should be given to the improvement of the research and development ability of domestic enterprises, universities and other institutions, using modern scientific and technological means to solve the problems of poor water solubility and strong toxic and side effects of monomers, so as to promote the clinical research of TCM monomers.

Keywords: traditional Chinese medicine monomers, anti-cancer, interventional clinical trials, research progress, adverse reactions