Chinese herbal medicine (Yiqi Huayu Jiedu Decoction) combined with chemotherapy for preventing postoperative recurrence and metastasis in elderly gastric cancer patients: protocol for a multicenter, double-blind, randomized, placebo-controlled trial

Abstract

Abstract Introduction Gastric cancer (GC) has a generally unfavorable prognosis. Elderly patients often tolerate dual-drug chemotherapy poorly, experience limited benefits from monotherapy, and face high rates of postoperative recurrence and metastasis. To address this unmet clinical need, this study evaluates the efficacy and safety of Yiqi Huayu Jiedu Decoction (YHJD) combined with chemotherapy in preventing recurrence and metastasis in elderly patients with stage II/III GC after surgery. Method This is a multicenter, double-blind, randomized, placebo-controlled trial conducted across twelve hospitals in China. A total of 302 elderly GC patients (age ≥ 65 years) with pathological stage pII/pIII after D2 resection will be randomized in a 1:1 ratio into the experimental group ( n = 151) and the control group ( n = 151). Patients will receive a 6-month treatment. The primary outcome is disease-free survival (DFS), and secondary outcomes include overall chemotherapy completion rate, overall survival (OS), Traditional Chinese Medicine (TCM) syndrome scores, and quality of life (QoL) assessments. Safety indicators such as adverse events (AEs), as well as exploratory analyses including big data analytics and gut microbiota diversity, will also be evaluated. Subgroup analyses will be conducted to explore the heterogeneity of YHJD effects. Discussion The results of this randomized controlled trial will provide objective evidence for evaluating YHJD as an adjuvant therapy after GC surgery, contributing to an integrated treatment strategy combining TCM and chemotherapy to prevent postoperative recurrence and metastasis in elderly GC patients. Trial registration International Traditional Medicine Clinical Trial Registry, available at: http://itmctr.ccebtcm.org.cn/ . Trial Registration number: ITMCTR2025001062. Registered on 09 May 2025.