Glioblastoma Response Prediction to Apatinib
Study on Predicting Response of Recurrent Glioblastoma to Apatinib
1 other identifier
observational
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedStudy Start
First participant enrolled
April 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJuly 21, 2023
July 1, 2023
1.7 years
March 22, 2021
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
genetic outcome
response prodicting biomarker
up to 2 years
Study Arms (3)
effective group
After treatment, tumor achieved complete response or partial response and the progression-free survival time was ≥6 months.
stable group
After treatment, tumor remains stable and the progression-free survival time was more than 1 month and less than 6 months.
Early progressed group
After treatment, tumor got progressed and the progression-free survival time was no more than 1 month.
Interventions
the underlying genetic characteristics that prodicting response
Eligibility Criteria
Neuro-oncology Department, Sanbo Bran Hospital Capital Medical University
You may qualify if:
- Age 18-70 years old
- recurrent glioblastoma
- received apatinib plus temozolomide treatment，response and survival data were available
- tumor tissues were acquired
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capital Medical University Sanbo Brain Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 24, 2021
Study Start
April 22, 2021
Primary Completion
December 31, 2022
Study Completion
June 30, 2023
Last Updated
July 21, 2023
Record last verified: 2023-07