Efficacy and safety of warming Yang and dredging intestines method in metastatic colon cancer maintenance.

Abstract

Background: There is a lack of integrated Chinese and Western medicine treatment regimens supported by high-level evidence-based medicine in the maintenance therapy phase of metastatic colorectal cancer (mCRC). Based on the traditional Chinese medicine theory of "Yin tumor", we believe that "Yang does not transform Yin, and it is blocked in the intestines" is the core pathogenesis of mCRC. Based on the basic treatment principle of "warming Yang and dredging intestines", we developed the Quxie Capsule. Previous randomized controlled clinical trials demonstrated that the Quxie Capsule can significantly prolong the overall survival of patients with mCRC, but it remains to be verified whether the combination of the "warming Yang and dredging intestines method" prescription with Western medicine standard regimen can prolong the efficacy and safety of the mCRC during the period of maintenance therapy.

Aim: To confirm and clinically validate that the combination of "warming Yang and dredging intestines method" prescription with Western medicine standard regimen can prolong progression-free survival (PFS) during maintenance treatment of mCRC. The safety of "warming Yang and dredging intestines method" prescription is also assessed.

Methods: The study has a prospective, open-label, randomized, controlled study design. Patients have been recruited beginning November 2023 from Xiyuan Hospital of China Academy of Chinese Medical Sciences, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Dongfang Hospital of Beijing University of Chinese Medicine, and Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine. The study period is from March 2024 to March 2026. After screening in outpatient clinics or wards, subjects who met the inclusion criteria are randomized into the treatment or control group in a 2:1 ratio. The treatment group receives the "warming Yang and dredging intestines method" formula combined with Western standard maintenance therapy. The control group receives Western standard maintenance therapy formulated by the investigators based on the Chinese Society of Clinical Oncology guidelines for colorectal cancer. All participants receive treatment until the occurrence of disease progression, death, or unmanageable adverse effects, with post-treatment monitoring continued until mortality. An independent panel of chief physicians with extensive clinical experience evaluates the progression of the disease.

Results: This study aims to clarify whether the combination of warming Yang and dredging intestines method formula with standard Western medicine regimens can prolong PFS during maintenance therapy for mCRC and whether the treatment has a favorable safety profile. The goal is to provide a combined Chinese and Western medicine treatment option for clinical physicians and mCRC patients. Notably, with the actual sample size, this study has an 80% probability of detecting a significant difference if a true difference exists. Small sample sizes may lead to increased instability of the results of subgroup analyses, and may also result in findings that are only applicable to patients with characteristics highly similar to those of the present study population (e.g., specific genotypes, therapeutic backgrounds, etc.), making it difficult to generalize to the broader mCRC population. In the future, it may be possible to expand the sample size based on this study to further validate the efficacy and safety of combining Chinese and Western medicine in the treatment of mCRC. Basic research on the therapeutic combination of warming Yang and dredging intestines method formula and standard Western regimen will be performed in parallel.

Conclusion: This study aims to clarify whether the combination of warming Yang and dredging intestines method formula with standard Western medicine regimens can prolong PFS during maintenance therapy for mCRC and whether the treatment has a favorable safety profile.