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

Last updated: May 5, 2022
Sponsor: Shanghai University of Traditional Chinese Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Adenocarcinoma

Gastric Cancer

Gastric Ulcers

Treatment

N/A

Clinical Study ID

NCT02781285
LONGHUA-2016-SH
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 kidneydysfunction, postoperative severe complications

Study Design

Total Participants: 1500
Study Start date:
December 01, 2014
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Longhua Hospital

    Shanghai, Shanghai 20032
    China

    Active - Recruiting

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