A clinical study on the efficacy of Yiqi Huayu Jiedu decoction for reducing the risk of postoperative recurrence and metastasis of gastric cancer

Abstract

Background: Gastric cancer (GC) is one of the top 10 malignant tumors worldwide and poses a great threat to human life and health, the prevention and treatment of which has become the focus and difficulty of medical research. With its unique advantages, traditional Chinese medicine (TCM) is widely used in the prevention and treatment of postoperative recurrence and metastasis of GC as well as the improvement of patients’ quality of life. The aim of this study is to elucidate the curative effect and the underlying mechanism of Yiqi Huayu Jiedu (YQHYJD) decoction. Methods/design: This is a prospective, multicenter, randomized controlled trial continuing 3 years. Two hundred ninety-eight eligible patients will be randomly divided into 2 groups, the chemotherapy combined with placebo and the chemotherapy combined with YQHYJD group at a ratio of 1:1. All patients will receive the treatment for 6 months and follow up for 3 years. The primary outcomes are disease-free survival, and 1-year, 2-year, 3-year progression-free survival rate, while the secondary outcomes are tumor makers, TCM syndrome score, quality of life score, overall chemotherapy completion rate, intestinal flora diversity test, immune function (T, B lymphocyte subsets and NK cells) test. The Security index includes blood, urine and stool routine, electrocardiogram, liver function (ALT), and renal function (BUN, Scr). All of these outcomes will be analyzed at the end of the trial. Discussion: This research will provide the valuable evidence for the efficacy and safety of Yiqi Huayu Jiedu decoction in postoperative GC. Furthermore, it will be helpful to form a higher level of evidence-based medical basis for TCM in the treatment of GC recurrence and metastasis. Trial registration: ChiCTR2000039038

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

“…Surgical treatment alone cannot improve the poor prognosis of advanced gastric cancer. Multimodal treatment approaches, with neoadjuvant chemotherapy as a representative, have a significant milestone significance in the treatment of advanced gastric cancer[7, 9, 13].…”

“…Our previous multi-center clinical study [12] has confirmed that YHJD decoction is effective in improving DFS rate in patients with gastric cancer stage III after radical gastrectomy. Meanwhile, another multi-center clinical study on the efficacy of YHJD for reducing the risk of postoperative recurrence and metastasis is being conducted [13]. However, these clinical studies are all combined with postoperative adjuvant chemotherapy, and no study was reported to evaluate whether the combination of YHJD and neoadjuvant chemotherapy can improve the postoperative pathological response rate of advanced gastric cancer.…”

Silencing of immunoglobulin superfamily containing leucine-rich repeat inhibits gastric cancer cell growth and metastasis by regulating epithelial–mesenchymal transition

“…GC is usually diagnosed at advanced stage, and recurrence and metastasis are the greatest challenges in the treatment process [ 30 ]. Although environmental factors, such as Helicobacter pylori infection, smoking, and diet, have been proven to be risk factors, host genetics also play a key role in GC occurrence [ 31 , 32 ].…”

Prediction of the mechanism of Jin Ling Zi Powder in the intervention of gastric cancer based on transcriptomics and network pharmacology

“…Traditional Chinese medicine (TCM), as one of the multimodal therapies, has a history of several thousand years. According to relevant studies, Chinese medicine, guided by a holistic concept, can effectively inhibit the invasion and metastasis of gastric cancer cells through local treatment or regulation of systemic status, which largely improves the prognosis of gastric cancer patients and enhances their quality of life [7][8].Studies have shown that gastric cancer has different subtypes and presents different characteristics, including clinical features, genetics, morphology, epidemiology and extension characteristics. Its development is closely related to high-risk factors such as diet, alcohol consumption, smoking, family history, Helicobacter pylori infection and Epstein-Barr virus (EBV) infection [9].Therefore, single-target drugs are no longer adequate for this complex multifactorial disease and there remains an urgent need to develop new therapeutic agents and strategies to improve the e cacy against this deadly disease.…”