Status:
NOT_YET_RECRUITING
Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer
Lead Sponsor:
Sir Run Run Shaw Hospital
Conditions:
Locally Advanced Colorectal Cancer
Postoperative Adjuvant Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 i...
Detailed Description
Colorectal cancer is the third leading cause of cancer-related deaths worldwide, with 1.9 million new cases and nearly 935,000 deaths reported in 2020. In China, colorectal cancer ranks third in new c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06596343
Start Date
October 1 2024
End Date
September 30 2027
Last Update
September 19 2024
Active Locations (1)
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1
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, China, China, 310016