NCT02668380

Brief Summary

This is an Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer, the investigators opted to give patients for apatinib 850 mg once daily, 28 days for a cycle. To evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

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, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

December 5, 2015

Last Update Submit

January 28, 2016

Conditions

Metastatic Gastric Cancer

Keywords

Apatinibmetastatic gastric cancerNon-interventionalStudy

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0.

    1 years

Secondary Outcomes (3)

  • Overall survival

    1 years

  • Progression-free survival

    8 months

  • Objective response rate

    5 months

Study Arms (1)

Apatinib

Apatinib Tablets: 850 mg,po, once daily , 28 days for a cycle

Eligibility Criteria

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

Advanced Metastatic Gastric Cancer

You may qualify if:

  • 》18 years old
  • Advanced Metastatic Gastric Cancer
  • The doctor evaluate that patients had benefit from treatment
  • The patients signed the written informed consent

You may not qualify if:

  • Apatinib has been confirmed for allergy sufferers
  • Pregnant or lactating women
  • Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100032, China

RECRUITING

Related Publications (2)

  • Li N, Bai C, Zhang R, Ma L, Ren X, Zhang J, Fu Z, Zhao L. Efficacy and safety of apatinib for the treatment of AFP-producing gastric cancer. Transl Oncol. 2021 Feb;14(2):101004. doi: 10.1016/j.tranon.2020.101004. Epub 2020 Dec 28.

    PMID: 33383486DERIVED

  • Wang X, Zhang R, Du N, Yang M, Zang A, Liu L, Yu J, Gao J, Zhang J, Fu Z, Ren Y, Ma L, Guo J, Li Q, Li X, Fan Z, Song X, Liu Z, Zhang Y, Li G, Yu Z, Diao J, Jia J, Liang F, Wang H, Sun J, Gao Y, Yang P, Bai C, Ren X, Zhong D. An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202). Ther Adv Med Oncol. 2020 Mar 19;12:1758835920905424. doi: 10.1177/1758835920905424. eCollection 2020.

    PMID: 32218807DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Chunmei Bai, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunmei Bai, MD

CONTACT

86-10-69155817baichunmei1964@163.com

Study Design

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

Study Record Dates

First Submitted

December 5, 2015

First Posted

January 29, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2018

Study Completion

May 1, 2019

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

CN(1)