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

May 5, 2022 updated by: Shanghai University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Both: both female and male participants are being studied

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1group one
patients with standard TCM diagnosis and treatment of gastric cancer
2 group two
patients take Chinese Medicine but not with standard TCM diagnosis and treatment of gastric cancer
3group three
patients take no Chinese Medicine

What is the study measuring?

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.
Time Frame: two years
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.
Time Frame: two years
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.
Time Frame: two years
Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 400 cases.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Fudan University
Shanghai Zhongshan Hospital
RenJi Hospital
Ruijin Hospital
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ShuGuang Hospital
Yunnan Provinical Hospital of Traditional Chinese Medicine
Shaanxi Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: zhao ai guang, Dr., Shanghai Longhua Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

May 15, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 24, 2016

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LONGHUA-2016-SH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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