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NCT04814329 Clinical Trial

Glioblastoma Response Prediction to Apatinib

Glioblastoma Clinical Trial

Official title:
Study on Predicting Response of Recurrent Glioblastoma to Apatinib

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04814329
Other study ID # 2021ZZLX03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 22, 2021
Est. completion date June 30, 2023

Study information
Verified date July 2023
Source Beijing Sanbo Brain Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Age 18-70 years old 2. recurrent glioblastoma 3. received apatinib plus temozolomide treatment,response and survival data were available 4. tumor tissues were acquired Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• genetic characteristic
the underlying genetic characteristics that prodicting response

Locations
Country Name City State
China Capital Medical University Sanbo Brain Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Sanbo Brain Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary genetic outcome response prodicting biomarker up to 2 years
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