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Evaluating the effect and mechanism of Yiqi Huayu Jiedu decoction combined with FLOT regimen neoadjuvant chemotherapy for the patients with locally advanced gastric cancer: protocol for a prospective, double-arm, randomized controlled clinical trial

  • Kun Zou1,#,
  • Pei-Chan Zhang1,2,#,
  • Chun-Yang Luo1,2,#,
  • Rui Wang1,2,
  • Shuo Xu3,
  • Chun-Jie Xiang4,
  • Xiang-Kun Huan1,
  • Wen-Chao Yao1,
  • Xiu-Yuan Li5,
  • Jun-Feng Zhang3 and
  • Shen-Lin Liu6,*
 Author information 

Abstract

Background

Neoadjuvant chemotherapy plays a vital role in the treatment of advanced gastric cancer (GC), however, optimizing its effectiveness remains an important research focus. Traditional Chinese medicine (TCM), a promising adjunctive therapy, has shown enhanced clinical outcomes when combined with postoperative adjuvant chemotherapy. Therefore, this study is designed to evaluate the clinical efficacy of Yiqi Huayu Jiedu decoction combined with neoadjuvant chemotherapy FLOT in the treatment of advanced GC.

Methods

This study is a prospective, double-arm, randomized controlled trial. It involves a total of 260 patients diagnosed with advanced GC, who will be randomly assigned to two groups - a TCM treatment group and a control group, each comprising 130 patients. All patients will receive standard FLOT chemotherapy, and patients in the TCM treatment group will additionally receive TCM treatment with Yiqi Huayu Jiedu decoction. After four cycles of chemotherapy, GC D2 radical surgery will be performed. The primary objective is to evaluate the postoperative pathological response rate of the tumor. The secondary objectives include evaluating the perioperative nutritional status, the efficacy of TCM syndrome, and adverse events associated with both chemotherapy and surgery.

Discussion

Currently, no trials have investigated the impact of TCM in combination with neoadjuvant chemotherapy on the preoperative treatment in patients with advanced GC. Accordingly, it is imperative to conduct this prospective study to evaluate the clinical efficacy and safety of this regimen, meanwhile providing high-level clinical evidence for TCM combined with neoadjuvant chemotherapy and introducing an innovative regimen for preoperative comprehensive treatment of GC.

Keywords

Yiqi Huayu Jiedu decoction, FLOT chemotherapy, Neoadjuvant chemotherapy, Gastric cancer
Copyright © 2025 Authors. This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 4.0 License (CC BY-NC 4.0), permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Zou K, Zhang PC, Luo CY, Wang R, Xu S, Xiang CJ, et al. Evaluating the effect and mechanism of Yiqi Huayu Jiedu decoction combined with FLOT regimen neoadjuvant chemotherapy for the patients with locally advanced gastric cancer: protocol for a prospective, double-arm, randomized controlled clinical trial. Gastroenterol & Hepatol Res. 2024;6(1):3. doi: 10.53388/ghr2024003.
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Article History
Received Revised Accepted Published
March 27, 2024
DOI http://dx.doi.org/10.53388/ghr2024003
  • Gastroenterology & Hepatology Research
  • eISSN 2703-173X
  • © 2025 Xia & He Publishing Inc.
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Evaluating the effect and mechanism of Yiqi Huayu Jiedu decoction combined with FLOT regimen neoadjuvant chemotherapy for the patients with locally advanced gastric cancer: protocol for a prospective, double-arm, randomized controlled clinical trial

Kun Zou, Pei-Chan Zhang, Chun-Yang Luo, Rui Wang, Shuo Xu, Chun-Jie Xiang, Xiang-Kun Huan, Wen-Chao Yao, Xiu-Yuan Li, Jun-Feng Zhang, Shen-Lin Liu
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