A clinical study of Yiqi Huayu Jiedu decoction reducing the risk of postoperative gastric cancer recurrence and metastasis: Study protocol for a randomized controlled trail
- Conditions
- Gastric Cancer
- Registration Number
- ITMCTR2000003294
- Lead Sponsor
- 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) Patients with pathological diagnosis of gastric cancer;
(2) Patients with histologically confirmed stage II, III after resection;
(3) Patients with criteria of TCM syndrome of Qi deficiency of spleen;
(4) KPS scores > 60;
(5) Patients aged from 18 to 70 years;
(6) Patients with life expectancy of at least 6 months;
(7) Patients who provide written informed consent to participate in the study according to the GCP criteria.
(1) Patients with metastatic gastric cancer;
(2) Patients with histologically or imaging examination confirmed local recurrence or distant metastasis;
(3) Patients who are pregnant, nursing;
(4) Patients with severe primary cardiovascular disease, liver disease, kidney disease, blood disease or other diseases affecting survival;
(5) Patients with disabilities are prescribed by law, including the blind, the deaf, dysgnosia, mental disturbance and extremity disability;
(6) Patients who are alcohol dependence or substance abuse;
(7) Patients with situations that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment;
(8) Patients who are allergic constitution,such as those who are allergic to more than 2 drugs and food, or those who are allergic to the ingredients of Jianpi Huayu Jiedu decoction;
(9) Patients who are participating in the other clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease-free survival;1 year progression-free survival rate;2 year progression-free survival rate;
- Secondary Outcome Measures
Name Time Method Quality of life;TCM sydrome score;tumor marker;