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
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Beijing
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Beijing, Beijing, China, 100032
- Recruiting
- Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
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Principal Investigator:
- Xiao yi Li, Doctor
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Contact:
- Lin Zhao, Master
- Phone Number: +86(10)69158315
- Email: wz20010727@aliyun.com
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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 |
|---|
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Apatinib
Apatinib Tablets: 850 mg,po, once daily , 28 days for a cycle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adverse Events
Time Frame: 1 years
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Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
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1 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: 1 years
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Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause.
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1 years
|
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Progression-free survival
Time Frame: 8 months
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A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.
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8 months
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Objective response rate
Time Frame: 5 months
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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.
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5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHEAD-G202
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