Jiangsu Famous Medical Technology Co., Ltd

The goal of this clinical trial is to learn whether Zhen-Qi-Jie-Du Granules combined with chemotherapy works to treat unresectable stage IV microsatellite-stable colorectal cancer in adults. It will also learn about the safety of Zhen-Qi-Jie-Du Granules when added to chemotherapy. The main questions it aims to answer are:
Does Zhen-Qi-Jie-Du Granules plus chemotherapy prolong progression-free survival compared with chemotherapy alone? Does Zhen-Qi-Jie-Du Granules improve disease control rate, objective response rate, cancer-related fatigue, myelosuppression, quality of life and traditional Chinese medicine syndrome for participants receiving chemotherapy? What medical problems and side effects do participants experience when taking Zhen-Qi-Jie-Du Granules alongside chemotherapy? Researchers will compare chemotherapy plus Zhen-Qi-Jie-Du Granules (intervention group) versus chemotherapy alone (control group). Participants may enter either a randomized controlled trial cohort or an observational cohort according to their own willingness.
Participants will:
Receive investigator-selected first-line, second-line or third-line standard chemotherapy regimens for advanced colorectal cancer Take Zhen-Qi-Jie-Du Granules (2 sachets, twice daily after breakfast and dinner) if assigned to the intervention group, for up to 6 months (or until treatment discontinuation criteria are met) Attend clinic visits for physical examination, vital signs, ECOG performance status assessment, laboratory blood and urine tests, chest and abdominal CT/MRI tumor imaging scans Complete validated questionnaires including FACIT-F, EORTC QLQ-C30, MDASI-TCM and the Late-Stage Colorectal Cancer TCM Syndrome Scale at scheduled visits Have adverse events, concomitant medications and survival status recorded throughout the study Provide plasma and stool biological samples at screening and scheduled follow-up visits Complete an End-of-Treatment (EOT) visit when stopping study treatment, regardless of the reason for discontinuation

This multicenter, randomized, double-blind, placebo-controlled trial will enroll 450 patients with completely resected high-risk colorectal adenoma (HR-CRA), randomly assigned (1:1) to 6 months of Shenbai Granules (SBG) or placebo, followed for 3 years post-polypectomy. Primary endpoint: 3-year cumulative incidence of metachronous HR-CRA. Secondary endpoints: incidence, number, size, distribution, histology of low-risk adenomas and serrated lesions, and colorectal cancer occurrence.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas（LRCRA）.
Study Population: Post-resection patients with low-risk colorectal adenomas and Spleen Deficiency with Dampness-Heat Syndrome per TCM criteria.
Sample Size: 450 subjects (1:1 randomization; 225 per arm) accounting for ≤20% dropout.
Study Hypothesis (Exploratory) ： This exploratory trial aims to evaluate the potential efficacy and safety of Shenbai Granules, a TCM formula, in reducing LRCRA recurrence. Based on preliminary data suggesting a 32.64% relative risk reduction in LRCRA recurrence at 2 years, we hypothesize that Shenbai Granules may demonstrate clinically meaningful prevention of adenoma recurrence and offer a favorable safety profile in the target TCM syndrome population. No formal statistical hypothesis is tested.
Statistical Analysis Analysis Sets: mITT (primary efficacy), PPS, SS (safety). Primary Analysis: Proportion difference (Newcombe method) and χ²/Fisher's exact test (stratified CMH if applicable).
Sensitivity analyses: PPS, tipping-point imputation for missing data. Safety: Descriptive summaries of AEs/SAEs (MedDRA-coded), lab abnormalities.