Gastric Carcinoma Clinical Trial
Official title:
Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer：A Randomized, Double-blind, Controlled and Multi-center Clinical Study
The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
This study include a multicenter, randomized, double-blind, placebo, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 212 patients. Participants will be randomly divided into experimental (n=106) and control groups (n=106).Patients in the experimental group was treated with Yiqiuyang Jiedu prescription within 6-8 months after radical gastroctomy and after the completion of standard regimen (XELOX and SOX) for at least 6 cycles of adjuvant chemotherapy. Patients in the control group will receive the placebo.The primary endpoint is 2-year DFS (Disease-free survival) rate after surgery, that refers to the proportion of patients who do not have recurrence, metastasis or death (from any cause) within 2 years after surgery. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial. ;
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