Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer

NCT06596343 · tracked via the Priya Life Science China tracker

Sponsor

Sir Run Run Shaw Hospital

Phase

Phase 2

Started

2024-10

Last updated

2024-09-19

Condition(s) studied

Locally Advanced Colorectal CancerPostoperative Adjuvant Therapy

Investigational drug(s) / intervention(s)

Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy

Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy: 1. Chemotherapy Regimen: * Postoperative adjuvant chemotherapy: A dual-drug concurrent regimen will be used, with each cycle lasting 21 days. On day 1 of each cycle, oxaliplatin will be administered intravenously at a dose of 130 mg/m². From day 1 to day 14 of each cycle, capecitabine will be taken orally at a dose of 1000 mg/m², twice daily. The treatment duration will follow the CSCO 2023 guidelines for colorectal cancer, with chemotherapy lasting for 6 months. 2. TCM Treatment: * TCM treatment will be based on syndrome differentiation ("Zheng") and guided by the Guidelines for TCM Diagnosis and Treatment of Malignant Tumors.

Study summary

This study aims to explore the role of Traditional Chinese Medicine (TCM) based on syndrome differentiation in reducing chemotherapy side effects, lowering the risk of metastasis and recurrence, and improving survival rates in postoperative colorectal cancer patients through a prospective, single-arm interventional clinical trial.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 1\. Age between 18 and 75 years. 2. Diagnosed with colorectal cancer at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and underwent standard radical colorectal cancer surgery. Postoperative pathological staging is stage III (AJCC 8th edition: T4, any N+, M0, or any T, N2, M0), indicating the need for chemotherapy according to the CSCO 2023 colorectal cancer guidelines. 3\. Willing to receive Traditional Chinese Medicine (TCM) treatment. 4. Voluntarily agree to participate in the study and sign the informed consent form. If the subject is unable to read or sign the consent due to incapacity, the informed consent must be obtained from a legal guardian. If the subject cannot read the consent (e.g., illiterate subjects), a witness must observe and sign the consent process. 5\. Expected survival of ≥12 months. 6. ECOG performance status score of 0-1. 7. No prior anti-cancer, immunotherapy, or radiation treatment. 8. Laboratory tests meeting the following criteria: * White blood cell count ≥3.5 × 10\^9/L, absolute neutrophil count ≥1.8 × 10\^9/L, platelet count ≥100 × 10\^9/L, hemoglobin ≥100 g/L. * INR ≤1.5 and APTT ≤1.5 times the upper limit of normal (ULN) or PTT ≤1.5 times ULN. * Total bilirubin ≤1.25 times ULN; ALT and AST ≤3 times ULN; serum albumin ≥28 g/L. * 24-hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5 times ULN. Exclusion Criteria: * 1\. Colorectal cancer patients with distant metastasis as indicated by preoperative evaluation. 2\. Postoperative pathological results indicate that chemotherapy is not required according to the CSCO 2023 colorectal cancer guidelines. 3\. Patients who have received neoadjuvant chemoradiotherapy before surgery. 4. Patients with severe heart, liver, kidney damage, or bone marrow dysfunction. 5\. Pregnant or breastfeeding women. 6. Patients with known allergies to Traditional Chinese Medicine components. 7. Patients who refuse chemotherapy or TCM treatment. 8. Patients with a history of mental illness or cognitive impairment.

Primary outcome measure(s)

The incidence of grade III/IV adverse events — From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy
According to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, adverse events (AEs) are graded on a scale from 1 to 5 based on severity: * Grade I: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention required. * Grade II: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADLs). * Grade III: Severe; medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs. * Grade IV: Life-threatening consequences; urgent intervention required. * Grade V: Death related to adverse event.

Trial sites (1)

Facility	City	Region	Status
Sir Run Run Shaw Hospital, Zhejiang University	Hangzhou	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06596343 on ClinicalTrials.gov ↗ ← All trials in China