Glioblastoma Response Prediction to Apatinib

Completed

• Conditions: Glioblastoma
• Interventions: Other: genetic characteristic

• Registration Number: NCT04814329
• Lead Sponsor: Beijing Sanbo Brain Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-04-22
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
stable group	genetic characteristic	After treatment, tumor remains stable and the progression-free survival time was more than 1 month and less than 6 months.
effective group	genetic characteristic	After treatment, tumor achieved complete response or partial response and the progression-free survival time was ≥6 months.
Early progressed group	genetic characteristic	After treatment, tumor got progressed and the progression-free survival time was no more than 1 month.

Primary Outcome Measures

Name	Time	Method
genetic outcome	up to 2 years	response prodicting biomarker

Trial Locations

Locations (1)

Capital Medical University Sanbo Brain Hospital; 🇨🇳 Beijing, China