NCT03478943

Brief Summary

The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

January 30, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

4.5 years

First QC Date

March 20, 2018

Last Update Submit

May 26, 2020

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

  • Progress free survival

    1 year

  • Disease-free surviva

    1 year

Secondary Outcomes (3)

  • overall survival

    3 year

  • Objective Response Rate

    1 year

  • Disease Control Rate

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients of gastric cancer in Henan province

You may qualify if:

  • Male or female patients .
  • Confirmed by Pathology or histology of Gastric cancer.
  • Patients should be voluntary to the trial and provide with signed informed consent.
  • The researchers believe patients can benefit from the study.

You may not qualify if:

  • Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories.
  • Pregnant or lactating women.
  • Patients with Apatinib contraindications.
  • Patients of doctors considered unsuitable for the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Suxia Luo

    Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

  • Peichun Sun

    Henan Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 27, 2018

Study Start

January 30, 2016

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

CN(1)