- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03735511
A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma
April 23, 2020 updated by: Henan Cancer Hospital
The study was designed to evaluate the efficacy and safety of apatinib in the treatment of patients with gastric carcinoma.
Study Overview
Status
Unknown
Conditions
Detailed Description
The study is a real-world non-interventional retrospective study and will collect the original medical records of patients with gastric carcinoma treated with apatinib from 2015 to 2018 in Henan Cancer Hospital.
Clinical data such as patient demographic, history of treatments, tumor biological characteristics and adverse events will be analyzed to evaluate the efficacy and safety of apatinib and explore the risk factors of prognosis in patients with gastric carcinoma.
Study Type
Observational
Enrollment (Actual)
270
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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Henan
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Zhengzhou, Henan, China, 450008
- Henan Cancer Hospital
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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
Probability Sample
Study Population
Chinese patients who were pathologically or cytologically diagnosed gastric carcinoma and treated by apatinib.
Description
Inclusion Criteria:
- Pathologically or cytologically confirmed gastric or residual gastric or gastroesophageal junction carcinoma;
- Patients received apatinib treatment at least once.
Exclusion Criteria:
1. No specific exclusion criteria in this real world study.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: 2015-2018
|
Overall Survival
|
2015-2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response Rate
Time Frame: 2015-2018
|
Objective Response Rate
|
2015-2018
|
|
Disease Control Rate
Time Frame: 2015-2018
|
Disease Control Rate
|
2015-2018
|
|
Progression-Free Survival
Time Frame: 2015-2018
|
Progression-Free Survival
|
2015-2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
November 20, 2018
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
November 7, 2018
First Submitted That Met QC Criteria
November 7, 2018
First Posted (Actual)
November 8, 2018
Study Record Updates
Last Update Posted (Actual)
April 27, 2020
Last Update Submitted That Met QC Criteria
April 23, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APA-GC-2018-HNZL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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