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
- Conditions
- gastric cancer
- Registration Number
- ITMCTR2100004250
- Lead Sponsor
- Department of Oncology, Jiangsu Province Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease-free survival;progression-free survival rate at 1, 2 and 3 years;
- Secondary Outcome Measures
Name Time Method Tumor markers;Detection of immune function (T, B lymphocyte subsets, NK cells);Quality of life score;Overall chemotherapy completion rate;Detection of intestinal flora diversity;TCM syndrome scores;