A clinical study on the efficacy of Yiqi Huayu Jiedu decoction for reducing the risk of postoperative recurrence and metastasis of gastric cancer Protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Department of Oncology, Jiangsu Province Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•(1) Pathological diagnosis meets the diagnostic criteria for GC, and TCM syndrome differentiation is weakness of spleen and stomach;
•(2) Pathologically confirmed stage III and has implemented radical surgery;
•(3) ECOG score <= 2, aged 18 to 75 years;
•(4) Estimated survival time is more than 6 months;
•(5) Patients are volunteer and has signed informed consents. The process of obtaining an informed consent complies with the GCP requirements.

•(1) Patients with metastatic gastric cancer;
•(2) Local recurrence or distant metastasis has been confirmed by histopathological or imaging examination;
•(3) Women during pregnancy and lactation;
•(4) Patients with severe primary cardiovascular, liver, renal or hematological disease;
•(5) Patients with serious primary heart, liver, lung, kidney, blood or other severe diseases that affect their survival;
•(6) Disabled patients (blind, deaf, dumb, mentally, mentally or physically disabled) as prescribed by law;
•(7) Suspected or existing history of alcohol or drug abuse;
•(8) Other lesions that may reduce the possibility of enrollment or complicate the enrollment according to the judgment of the researcher, such as frequent changes of the work environment, that may easily lead to loss of follow-up;
•(9) Allergic constitution, such as two or more drugs or food allergies; Or known to be allergic to the ingredients of YQHYJD decoction ;
•(10) Patients who are participating in clinical studies of other drugs.

发起方

Department of Oncology, Jiangsu Province Hospital of Chinese Medicine