NCT03333967

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 Sep 2017

Typical duration 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

September 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 7, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

October 1, 2017

Last Update Submit

November 6, 2017

Conditions

Keywords

apatinib

Outcome Measures

Primary Outcomes (1)

  • Progress free survival

    Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

    1 year

Secondary Outcomes (4)

  • disease control rate

    1year

  • Objective tumor response rate

    1year

  • overall survival

    3year

  • Disease-free survival

    1 year

Other Outcomes (2)

  • Quality of life score

    1year

  • adverse events

    1year

Eligibility Criteria

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

patients of gastric cancer in Anhui 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)

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

Related Publications (2)

  • Peng W, Zhang F, Wang Z, Li D, He Y, Ning Z, Sheng L, Wang J, Xia X, Yu C, Wang Z, Zhao Y, Liang H, Hu B, Sun C, Wang D, Cheng Y, Pan M, Xia L, Guo X, Zhang Y, Hu Z, Li X, Lu L, Zhang J, Qian H, Xie H, Sun G. Large Scale, Multicenter, Prospective Study of Apatinib in Advanced Gastric Cancer: A Real-World Study from China. Cancer Manag Res. 2020 Aug 6;12:6977-6985. doi: 10.2147/CMAR.S249153. eCollection 2020.

  • Du Y, Cao Q, Jiang C, Liang H, Ning Z, Ji C, Wang J, Zhou C, Jiang Z, Yu C, Li L, Zhao Y, Xu Y, Xu T, Hu W, Wang D, Cheng H, Wang G, Zhou J, Wang S, Zhang Y, Hu Z, Li X, Lu D, Zhang J, Xie H, Sun G. Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study. Cancer Med. 2020 Jul;9(14):5008-5014. doi: 10.1002/cam4.3105. Epub 2020 May 22.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • China Anhui

    The First Affiliated Hospital of Anhui Medical University

    STUDY CHAIR

Central Study Contacts

guoping sun, doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 1, 2017

First Posted

November 7, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

November 7, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

Locations