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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2022-12-31

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.

Conditions

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Gastric Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

ShuGuang Hospital

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Yunnan Provinical Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Shaanxi Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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zou yu ming, Ma.

Role: CONTACT

15021827856

zhao ai guang, Dr.

Role: CONTACT

13661472241

Facility Contacts

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zou yu ming, Ma.

Role: primary

15021827856

zhao ai guang, Dr.

Role: backup

13661472241

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.

Reference Type BACKGROUND
PMID: 21296855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16873996 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38801641 (View on PubMed)

Other Identifiers

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LONGHUA-2016-SH

Identifier Type: -

Identifier Source: org_study_id

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