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

Launched by SIR RUN RUN SHAW HOSPITAL · Sep 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how Traditional Chinese Medicine (TCM) can help patients with locally advanced colorectal cancer after they have had surgery. Researchers want to see if TCM can reduce the side effects of chemotherapy, lower the chances of cancer returning or spreading, and ultimately improve survival rates for these patients. The trial is a Phase 2 study, meaning it’s testing the effectiveness and safety of TCM in a group of participants.

To be eligible for the study, participants must be between 18 and 75 years old, have been diagnosed with colorectal cancer, and have undergone standard surgery for it. They should also be willing to receive TCM treatment and have a good expected survival chance. Participants will be supported throughout the trial and may experience a different approach to their recovery that includes TCM alongside standard care. It's important to know that the trial is not yet recruiting participants, but it aims to help improve treatment options for colorectal cancer patients in the future.

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Eligibility criteria

• 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.