Colorectal Cancer
Conditions
Interventions
Control Group:Administration of matched placebo on the basis of conventional treatment
Experimental Group:Administration of Guben Xiaoji Granule on the basis of conventional treatment
Sponsors
Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age and Gender: 18–75 years old, no gender restriction. 2.Pathological Confirmation and Staging: Pathologically confirmed colorectal adenocarcinoma (including mucinous adenocarcinoma and other subtypes) based on surgical specimens (primary tumor or regional lymph nodes); staged as IIB–IIIC according to the 8th edition of the AJCC Cancer Staging Manual. 3.Radical Resection and Margin Status: Completion of R0 radical resection (microscopically negative margins). 4.Exclusion of Postoperative Distant Metastasis (Including Liver): Completed within =28 days prior to randomization: thin-slice chest CT and contrast-enhanced abdominopelvic CT; contrast-enhanced liver MRI with Gd-EOB-DTPA (or triple-phase contrast-enhanced CT) showing no distant metastases. For rectal cancer patients, additional high-resolution pelvic MRI is required for stratification. 5.Timing of Adjuvant Therapy: Planned to receive or have initiated standard adjuvant therapy (guideline-recommended regimens such as CAPOX, FOLFOX) within =4 weeks; randomization must occur either before initiation or within =4 weeks after initiation of adjuvant therapy. 6.High-Risk Features for Hepatic Metastasis (Meeting =1 Criterion): 1) T4 or N2 stage; 2) Positive LVI/PNI (vascular/perineural invasion documented in pathological report); 3) Right-sided primary tumor (from cecum to proximal transverse colon, including ascending colon and hepatic flexure); 4) High tumor budding (Bd3 according to ITBCC criteria, =10 buds/0.785 mm²; or equivalent institutional threshold). 7.Performance Status: ECOG performance status 0–1. 8.Adequate Organ Function to Tolerate Treatment: Baseline laboratory values meeting the following criteria: ANC =1.5×10 9/L; PLT =100×10 9/L; Hb =90 g/L; ALT/AST =2.5×ULN; T-Bil =1.5×ULN; eGFR =50 mL/min/1.73 m2; INR =1.5 or within a stable anticoagulant range. 9.Expected Survival: Clinically assessed life expectancy =2 years, with ability to complete the protocol-specified treatment and follow-up. 10.Compliance and Informed Consent: Subjects must sign a written informed consent form, agreeing to complete study visits, imaging examinations, and biological sample collection as specified in the protocol, with compliance documentation permitted via electronic means.
Exclusion criteria
Exclusion criteria: 1.Other Malignant Tumors: Active malignant tumors present or under treatment within the past 5 years (exceptions: curatively resected basal/squamous cell carcinoma of the skin, or in situ carcinoma of the cervix/breast with no recurrence for =3 years). 2.Residual/Metastatic Disease: R1/R2 resection margins after surgery; any distant metastases (including liver, lung, peritoneum, bone, etc.) identified on imaging prior to randomization, or suspicious lesions not excluded by protocol-specified re-evaluation. 3.Significant Liver Disease or Uncontrolled Active Viral Hepatitis: Child-Pugh class B/C; history of hepatic encephalopathy, refractory ascites, or variceal bleeding; HBsAg-positive with HBV DNA >2,000 IU/mL without standardized suppression, or HCV RNA-positive with persistently abnormal transaminases; unexplained laboratory findings of ALT/AST >2.5×ULN or T-Bil >1.5×ULN. 4.Severe/Active Infections: Active tuberculosis, invasive bacterial/fungal infections. 5.Autoimmune Diseases/Transplant Requiring Systemic Immunosuppression: Long-term maintenance with =10 mg/day prednisone equivalent or biological agents; solid organ transplant recipients. 6.Major Cardiopulmonary Diseases: NYHA class III-IV heart failure; myocardial infarction, unstable angina, stroke, or TIA within =6 months; uncontrolled hypertension (=160/100 mmHg); significant QTc prolongation (males >450 ms, females >470 ms); active interstitial lung disease or GOLD class III-IV COPD. 7.Gastrointestinal Conditions Precluding Oral Administration/High Bleeding Risk: Short bowel syndrome/malabsorption, persistent gastrointestinal obstruction =grade 2, active peptic ulcer, or bleeding diathesis. 8.Failure to Meet Key Laboratory Thresholds: ANC 1.5 (unstable anticoagulation), eGFR <50 mL/min/1.73 m2, or refractory electrolyte disturbances. 9.Pregnancy/Lactation or Inadequate Contraception: Pregnant or lactating subjects; women of childbearing potential unwilling to use reliable contraception from enrollment until 6 months after the last dose. 10.Contraindications/Conflicts and Compliance Issues: Severe allergy to study drugs or iodine/gadolinium contrast agents that cannot be premedicated; participation in other interventional trials within =30 days or inability to discontinue prohibited medications (e.g., other TCM compounds, potent immunomodulators, per SOP); poor recovery from major surgery within =28 days; confirmed poor compliance or investigator-determined ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hMFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS;MFS;OS;Site of First Recurrence;NCI-CTCAE v5.0;Improvement in Quality of Life;Changes in Traditional Chinese Medicine (TCM) Syndrome Scores; | — |
Countries
China
Contacts
Public ContactWei PENG
Hunan Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed