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

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.

Effect of Jianpi-yangwei decoction on gut fungi in the patients with gastric cancer undergoing chemotherapy

Background:Our previous study shows that the empirical formula of Chinese medicine Jianpi-yangwei decoction(JYD)can improve the quality of life in patients with gastric cancer undergoing chemotherapy by increasing beneficial gut bacteria and decreasing harmful bacteria.The present study aims to investigate the effect of JYD on gut fungi in patients with gastric cancer undergoing chemotherapy.Methods:A total of 73 patients with gastric cancer undergoing chemotherapy were recruited.Twenty-nine patients in the chemotherapy group were given standard chemotherapy and 44 patients in the observation group were given JYD plus standard chemotherapy.A control group(55 cases)was recruited from the healthy medical examiners.After 3 months of treatment,life-quality score was evaluated and fecal microbiota was tested by high-throughput sequencing based on the 18S rRNA gene.Results:After treatment,life-quality score in the observation group was significantly lower than that in the chemotherapy group(P<0.05).There was no significant difference between the observation and control groups’diversity and richness indices of intestinal fungi.The Chao index for intestinal fungi in the chemotherapy group was significantly lower than that in the observation group(P<0.05).There was a significant difference between the control and chemotherapy groups in the intestinal fungi according to Shannon and Simpson indices(P<0.05).Linear discriminant analysis effect size analysis showed no significant differences among the three groups,but significant difference in intestinal fungi was observed between the observation group and the chemotherapy group.At the genus level,the relative abundance of the Aspergillus genus in the observation and control groups was significantly lower(P<0.05),the relative abundance of the Cutaneotrichosporon,Galactomyces,and Ganoderma genus taxa was significantly higher compared with those in the chemotherapy group(P<0.05),and there was no significant difference between the observation group and control group.Conclusion:JYD can ameliorate chemotherapy-induced fungal dysbacteriosis in patients with gastric cancer undergoing chemotherapy and improve the quality of life of patients.