NCT02781285

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

7.8 years

First QC Date

May 15, 2016

Last Update Submit

May 5, 2022

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Both: both female and male participants are being studied

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital

Shanghai, Shanghai Municipality, 20032, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 21296855BACKGROUND

  • 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.

    PMID: 16873996BACKGROUND

  • 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.

    PMID: 38801641DERIVED

Study Officials

  • zhao ai guang, Dr.

    Shanghai Longhua Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

zou yu ming, Ma.

CONTACT

15021827856zoubush133136@hotmail.com

zhao ai guang, Dr.

CONTACT

136614722412538312201@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2016

First Posted

May 24, 2016

Study Start

December 1, 2014

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)