Glioblastoma Response Prediction to Apatinib

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

• Status: Completed
• Conditions: Glioblastoma
• Intervention / Treatment: Other: genetic characteristic

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Capital Medical University Sanbo Brain Hospital

Participation Criteria

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:

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
effective group; After treatment, tumor achieved complete response or partial response and the progression-free survival time was ≥6 months.	Other: genetic characteristic; 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.	Other: genetic characteristic; 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.	Other: genetic characteristic; the underlying genetic characteristics that prodicting response

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genetic outcome	response prodicting biomarker	up to 2 years

Collaborators and Investigators

• Sponsor: Beijing Sanbo Brain Hospital

Study record dates

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

• Keywords: Biomarkers; glioblastoma; Vascular Endothelial Growth Factor Receptor 2
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• 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