Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score

Study Overview
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Brief Summary
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The researching subject is aimed to obtain the clinical evidences (including real benefits， risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by compared with the outcomes that not accept the traditional Chinese medicine. the subject acquires these clinical practices by using the methods of multicenter、persisting registry (the real world researching technology ) and propensity score.

Detailed Description
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The purpose of this project is to further evaluate the role of traditional Chinese medicine in the treatment of advanced gastric cancer through clinical registration along with real world study. The patients who suffer from advanced gastric cancer often have a very short time survival . Their total survival time is only 4.3 months after the best supportive care. At present palliative chemotherapy is still the main method for advanced gastric cancer . In recent years, the results of international multi center phase III clinical trial show that the patients with combination chemotherapy have 8.6 months to 13.0 months survival time. In China, the clinical curative effect of traditional Chinese medicine in the treatment of advanced gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the Traditional Chinese Medicine may prolong the survival and improve the quality of life in patients with advanced gastric cancer. Real World Study emphasizes in epidemiological theories, clinical observational study, cross-sectional study and cohort study. The observational study of registry (registry study in clinical practice) is particularly widely used. Clinical practice of traditional Chinese medicine in the treatment of advanced gastric cancer often relies on the accumulation of years of medical experiences and sometimes new treatment measures. There must be some objective evidences that with reasonable design, rigorous process, scientific statistics to evaluate the value of traditional Chinese medicine intervention in the comprehensive treatment of advanced gastric cancer patients in order to meet the needs of clinical practice and medical development in China.

Official Title
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Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score Through Registration

Conditions
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Gastric Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gastric adenocarcinoma without operation or recurrence after operation or metastasis diagnosed within three months KPS score≥60 expected survival time was above 3 months HB ≥80g/L 、WBC≥4.0×109/L、 N ≥2.0×109/L 、PLA ≥80×109/L normal function with heart 、kidney and liver Exclusion Criteria: not gastric adenocarcinoma simultaneous diagnosis with other malignant tumor participate in clinical trials of new drugs not listed in China combined with myocardial infarction, cerebral infarction, severe liver and kidney dysfunction, postoperative severe complications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1group one<br>patients with standard TCM diagnosis and treatment of gastric cancer | |
| 2 group two<br>patients take Chinese Medicine but not with standard TCM diagnosis and treatment of gastric cancer | |
| 3group three<br>patients take no Chinese Medicine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influences of traditional Chinese medicine standardized treatment on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. | Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 725 cases . | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influences of traditional Chinese medicine treatment but with standardization scheme on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. | Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 375 cases. | two years | 
| The influences of Western Medicine treatment mainly by chemotherapy on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. | Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 400 cases. | two years |