Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score
NCT ID: NCT02781285
Last Updated: 2022-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1500 participants
OBSERVATIONAL
2014-12-31
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1group one
patients with standard TCM diagnosis and treatment of gastric cancer
No interventions assigned to this group
2 group two
patients take Chinese Medicine but not with standard TCM diagnosis and treatment of gastric cancer
No interventions assigned to this group
3group three
patients take no Chinese Medicine
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
RenJi Hospital
OTHER
Fudan University
OTHER
ShuGuang Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Ruijin Hospital
OTHER
Yunnan Provinical Hospital of Traditional Chinese Medicine
OTHER
Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Shaanxi Hospital of Traditional Chinese Medicine
OTHER
Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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zhao ai guang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Longhua Hospital
Locations
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Longhua Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
Yilmaz U, Oztop I, Alacacioglu A, Yaren A, Tarhan O, Somali I. Irinotecan combined with infusional 5-fluorouracil and high-dose leucovorin for the treatment of advanced gastric carcinoma as the first-line chemotherapy. Chemotherapy. 2006;52(5):264-70. doi: 10.1159/000094769. Epub 2006 Jul 26.
Cao ND, Zhu XH, Ma FQ, Xu Y, Dong JH, Qin MM, Liu TS, Zhu CC, Guo WJ, Ding HH, Guo YB, Liu LK, Song JJ, Wu JP, Cheng YL, Zeng L, Zhao AG. Chinese Medicine Prolongs Overall Survival of Chinese Patients with Advanced Gastric Cancer: Treatment Pattern and Survival Analysis of a 20-Year Real-World Study. Chin J Integr Med. 2024 Jun;30(6):489-498. doi: 10.1007/s11655-024-4107-8. Epub 2024 May 27.
Other Identifiers
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LONGHUA-2016-SH
Identifier Type: -
Identifier Source: org_study_id
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