An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer (AHEAD-G202)

January 28, 2016 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Unknown

Conditions

Detailed Description

In the last decade, front-line chemotherapy has been considered a standard therapeutic regimen for the extension of survival time in patients with metastatic gastric cancer (mGC). New evidence suggests that salvage chemo-therapies, as second-line treatments, may have a survival advantage when compared with best supportive care. After failure of second-line chemotherapy, the results of further treatment are poor, yielding response rates of 0% to 5% with no evidence of prolonged survival. Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor, Had been approved by the CFDA for the treatment of advanced gastric cancer, However, this study defines a variety of inclusion/exclusion criteria, efficacy and safety are not well reflect in the real world for the treatment of advanced gastric cancer. Therefore, an Open Label, Prospective, Multicentre, Non-interventional Study could evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Xiao yi Li, Doctor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced Metastatic Gastric Cancer

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  • Doctors think doesn't inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 1 years
Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 years
Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause.
1 years
Progression-free survival
Time Frame: 8 months
A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.
8 months
Objective response rate
Time Frame: 5 months
Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Chunmei Bai, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

December 5, 2015

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHEAD-G202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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