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Colorectal cancer is one of the most common and fatal cancers worldwide. Despite therapeutic advancements, patients with stage II and III colon cancer often experience recurrences and metastases, particularly to the liver, leading to suboptimal disease-free survival (DFS) rates and decreased long-term survival. Qu-Shi-Jie-Du decoction (QSJDD), a traditional Chinese herbal formula, may prevent cancer recurrence and spread by boosting immunity, reducing inflammation, and inhibiting tumour growth. Preliminary studies have demonstrated that QSJDD reduces liver metastasis in patients with colon cancer. However, robust clinical evidence is required to confirm its efficacy and safety.

This study aims to evaluate the safety and efficacy of QSJDD in preventing colon cancer recurrence and liver metastasis, thereby offering a potential adjunctive therapy to improve patient outcomes.

This multicentre, double-blind, randomised, placebo-controlled trial involves 336 high-risk stage II or III colon cancer patients from 10 Chinese hospitals. Post-surgery and chemotherapy, 168 patients will receive either QSJDD compound granules or a placebo for 6 months, with a 3-year follow-up and evaluations every 6 months. The primary endpoint is to measure the 3-year DFS rate, while secondary endpoints include 1- and 2-year DFS rates, overall survival, and changes in the Traditional Chinese Medicine Dampness Syndrome Scale. Safety and adverse events will be tracked, and blood and gut microbiomes will be analysed to assess QSJDD's impact on delaying colon cancer metastasis.

This trial will determine the efficacy and safety of QSJDD and provide evidence regarding its role in the adjuvant treatment of colon cancer.