Study for the innovative clinical protocol and application of treating gastric cancer by the rule of ''the body and spirit, stasis, toxin and depression together''
- Conditions
- Gastric cancer
- Registration Number
- ITMCTR2000003330
- Lead Sponsor
- Affiliated Cancer Hospital of Zhejiang Chinese Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. The patients with TNM stage III gastric cancer were diagnosed by pathology, and D2 radical operation had been performed, and chemotherapy had not been started;
2. The syndrome differentiation of traditional Chinese medicine is the syndrome of stasis, toxin and depression;
3. Patients aged 18 to 75 years;
4. Patients with good general condition and ECoG score <=2;
5. The subjects must have informed consent before the test, fully understand the test content, process and possible adverse reactions, and sign the written informed consent voluntarily.
1. Patients with gastric cancer metastasis or recurrence, or with other tumors within 5 years;
2. Patients with expected survival time <=3 months;
3. Patients with severe malnutrition, primary diseases of heart, brain, lung, liver, kidney, endocrine, blood, nervous system or other acute and chronic diseases that may significantly affect the treatment and prognosis;
4. Patients with history or risk of epilepsy;
5. Patients with dementia or severe mental disorder who cannot understand or express informed consent;
6. Current or previous patients with a history of alcohol or drug abuse or drug abuse;
7. Male subjects (or their partners) or female subjects have birth plans or egg donation plans within 28 days before screening and 6 months after the last administration of the study drug, and are unwilling to take one or more non drug contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) during the trial period;
8. Pregnant, pregnant or lactating patients;
9. Patients who are participating in other clinical studies;
10. Patients who are allergic to the test drug and its components;
11. Patients who can not swallow tablets or traditional Chinese medicine decoction, malabsorption syndrome or any condition affecting gastrointestinal absorption;
12. Patients with active tuberculosis (TB) are receiving anti TB treatment or have received anti TB treatment within one year before screening;
13. Patients who were not considered suitable for the study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year disease-free survival, DFS;
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep quality score scale;Evaluation of weight change;Hamilton anxiety scale;1-year survival rate: end point evaluation;Living ability score;Quality of Life scale (QOL-C30);Hamilton Depression scale;Completion rate and delay rate of chemotherapy;Curative effect score of TCM syndrome;