Glioblastoma Response Prediction to Apatinib
July 20, 2023 updated by: Junping Zhang, Beijing Sanbo Brain Hospital
Study on Predicting Response of Recurrent Glioblastoma to Apatinib
Anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma.
Our previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal antibody against VEGFR-2, when added to temozolomide chemotherapy in patients with recurrent glioblastoma.
Some patients showed durable responses and prolonged survival, with recorded survival times of over 30 months in 6.4% patients.
However, a subset of patients progressed in 2 months.
There is a strong need to better predict and monitor apatinib treatment response to prevent patients from adverse effects of ineffective therapy.
In this study, whole genome sequencing and RNA-sequencing of formalin-fixed, paraffin-embedded tumor materials from the participants who received apatinib and temozolomide treatment will be performed to identify the response biomarkers and patients who may benefit most from apatinib, avoiding unnecessary potential toxicity and cost for those who are unlikely to benefit from the drug.
Study Overview
Study Type
Observational
Enrollment (Actual)
18
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, China
- Capital Medical University Sanbo Brain 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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Neuro-oncology Department, Sanbo Bran Hospital Capital Medical University
Description
Inclusion Criteria:
- Age 18-70 years old
- recurrent glioblastoma
- received apatinib plus temozolomide treatment，response and survival data were available
- tumor tissues were acquired
Exclusion Criteria:
-
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 |
Intervention / Treatment |
|---|---|
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effective group
After treatment, tumor achieved complete response or partial response and the progression-free survival time was ≥6 months.
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the underlying genetic characteristics that prodicting response
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stable group
After treatment, tumor remains stable and the progression-free survival time was more than 1 month and less than 6 months.
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the underlying genetic characteristics that prodicting response
|
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Early progressed group
After treatment, tumor got progressed and the progression-free survival time was no more than 1 month.
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the underlying genetic characteristics that prodicting response
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
genetic outcome
Time Frame: up to 2 years
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response prodicting biomarker
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up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 22, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
March 22, 2021
First Submitted That Met QC Criteria
March 22, 2021
First Posted (Actual)
March 24, 2021
Study Record Updates
Last Update Posted (Actual)
July 21, 2023
Last Update Submitted That Met QC Criteria
July 20, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021ZZLX03
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.