• Zhi-Jie Wang, Shi-Hang Zheng, Xiao-Han Wang, Yi-Zhe Zhang, Shu-Lan Hao, Li-Kun Liu, and Xi-Xing Wang.
• Department of Oncology, Shanxi Province Hospital of Traditional Chinese Medicine, Taiyuan, China.
• Medicine (Baltimore). 2021 Dec 23; 100 (51): e28040e28040.

IntroductionColorectal cancer has been ranked third among the most common cancers worldwide and raised to the second leading cause of cancer death with nearly one-tenth of cancer-related deaths globally, and nearly half of colorectal cancer patients present with or develop colorectal cancer liver metastasis (CRLM). Buzhong Tiaogan Formula (BTF) has been proven to treat CRLM in our team, but there are lacking of evidence on its effective in delaying colorectal liver metastasis (liver depression spleen deficiency type), so we will evaluate the efficacy and safety of BTF in preventing the occurrence of CRLM.MethodsThis randomized controlled trial (RCT) will be carried out in 3 different hospitals in Shanxi Province planning to recruit 150 CRLM patients with the type of liver depression spleen deficiency. The control group will be treated by basic antitumor therapy and the treatment group will use BTF plus basic antitumor therapy. The primary outcomes will be quality of life of included patients, the time of occurrence of liver metastasis, the score of traditional Chinese medicine symptom for the type of liver depression spleen deficiency; and the secondary outcomes will include overall survival, progression-free survival, DFS, tumor microenvironment and immune state of the included patient. Safety evaluation will be recorded during the whole study. All data in this RCT will be analyzed by SPSS 23.0 software. This study has been approved by the Clinical Research Ethics Committee of Shanxi Province Hospital of Traditional Chinese medicine (2021Y-06016).DiscussionThe results of this RCT will contribute to BTF for delaying colorectal liver metastasis (liver depression spleen deficient type). And the results from this RCT will be published in a relevant journal after finished.Trial RegistrationChiMCTR2100005268 (September 4, 2021).Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

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