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.
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.
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.
1. Colorectal cancer patients with distant metastasis as indicated by preoperative evaluation.
Single group
Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy
Drug1. 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.
The incidence of grade III/IV adverse events
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.
3-year Disease-Free Survival
3-year Disease-Free Survival (DFS) refers to the percentage of patients who remain free from any signs or symptoms of cancer recurrence or progression for three years after treatment.
3-year Overall Survival
3-year Overall Survival (OS) refers to the percentage of patients who are still alive three years after the start of treatment, regardless of whether the cancer has recurred or progressed.
Completion rate of adjuvant chemotherapy
The completion rate of adjuvant chemotherapy is defined as the percentage of patients who successfully complete the full chemotherapy regimen within 6 months post-surgery, in accordance with the CSCO 2023 guidelines for colorectal cancer
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a widely used tool for assessing the quality of life of cancer patients in clinical trials. Each subscale of the EORTC QLQ-C30 is scored on a range from 0 to 100. Score Interpretation: Higher Scores: For functional scales (e.g., physical, role, emotional, cognitive, social functioning): Higher scores indicate a better quality of life. For symptom scales (e.g., fatigue, pain, nausea/vomiting): Higher scores indicate worse symptoms or problems. The global health status/QoL scale: Higher scores indicate a better overall quality of life.
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