Xian-Lian-Jie-Du Optimization Decoction as Additional Treatment for Preventing Recurrence of Stage IIIB/IIIC Colon Cancer A Randomized, Double-Blind, Placebo-Controlled Trial

What this Trial Is About

Researchers are investigating the use of the XLJDOD compound granule as an additional treatment to prevent the recurrence of stage IIIB or IIIC colon cancer after standard chemotherapy. This phase 3, multi-center, randomized, double-blind, placebo-controlled trial compares XLJDOD to a placebo (XLJDOD mimetic agent) to evaluate its impact on disease-free survival over two years. Participants will begin treatment within three months after completing standard adjuvant chemotherapy. Those in the intervention group will take XLJDOD compound granules twice daily, one hour after lunch and dinner, infused with warm water. Each treatment course lasts 28 days followed by a 2- to 3-day rest, with a total of six courses. The control group will follow the same schedule but receive the placebo instead. During the study, researchers will monitor treatment compliance and safety while assessing disease recurrence through regular evaluations. The primary outcome is disease-free survival measured 24 months after randomization. Participants will be followed for at least two years to determine the effectiveness of the treatment in preventing cancer recurrence.

Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer