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

Abstract Background Neoadjuvant chemotherapy plays a vital role in the treatment of advanced gastric cancer, 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 gastric cancer. Methods This study is a prospective, double-arm, randomized controlled trial. It involves a total of 260 patients diagnosed with advanced gastric cancer, 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 traditional Chinese medicine treatment with Yiqi Huayu Jiedu decoction. After four cycles of chemotherapy, gastric cancer 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 traditional Chinese medicine syndrome, and adverse events associated with both chemotherapy and surgery. Discussion Currently, no trials have investigated the impact of traditional Chinese medicine in combination with neoadjuvant chemotherapy on the preoperative treatment in patients with advanced gastric cancer. 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 traditional Chinese medicine combined with neoadjuvant chemotherapy and introducing an innovative regimen for preoperative comprehensive treatment of gastric cancer. Trial registration ChiCTR2300072742