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Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05229809
Study type Interventional
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Guanghui Zhu, Doctor
Phone +86 13315714979
Email zhugh0822@163.com
Status Recruiting
Phase Phase 4
Start date March 1, 2022
Completion date July 31, 2024

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