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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSir Run Run Shaw Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

1. Colorectal cancer patients with distant metastasis as indicated by preoperative evaluation.

Trial design

Treatments tested in this trial

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

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators