Glioblastoma Response Prediction to Apatinib

NCT ID: NCT04814329

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-22

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Glioblastoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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effective group

After treatment, tumor achieved complete response or partial response and the progression-free survival time was ≥6 months.

genetic characteristic

Intervention Type OTHER

the underlying genetic characteristics that prodicting response

stable group

After treatment, tumor remains stable and the progression-free survival time was more than 1 month and less than 6 months.

genetic characteristic

Intervention Type OTHER

the underlying genetic characteristics that prodicting response

Early progressed group

After treatment, tumor got progressed and the progression-free survival time was no more than 1 month.

genetic characteristic

Intervention Type OTHER

the underlying genetic characteristics that prodicting response

Interventions

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genetic characteristic

the underlying genetic characteristics that prodicting response

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Sanbo Brain Hospital

OTHER

Sponsor Role lead

Responsible Party

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Junping Zhang

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Capital Medical University Sanbo Brain Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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2021ZZLX03

Identifier Type: -

Identifier Source: org_study_id

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