Bevacizumab Neoadjuvant Therapy for New High-grade Gliomas in the Brain

Glioblastoma (GBM) usually grows in a diffuse fashion and infiltrates the surrounding brain. The inability to completely excise the tumor often leads to tumor recurrence within a few months of the initial surgery, which ultimately results in the death of the GBM patient.GBM histologically appears to be a tumor of vascular origin characterized by necrosis and microvascular proliferation, and neoangiogenesis is a key factor in the growth and poor prognosis of GBM. Bevacizumab can inhibit the biological effects of VEGF, including the permeability and proliferation of blood vessels, as well as the migration and survival of endothelial cells, so as to inhibit tumor angiogenesis, growth and metastasis. The aim of this study is to evaluate the efficacy and safety of bevacizumab in the preoperative adjuvant treatment of patients with new-onset high-grade gliomas.

Study Overview

• Status: Recruiting
• Conditions: Brain Glioma
• Intervention / Treatment: Drug: Bevacizumab

Detailed Description

Glioblastoma (GBM) usually grows in a diffuse fashion and infiltrates the surrounding brain. The inability to completely excise the tumor often leads to tumor recurrence within a few months of the initial surgery, which ultimately results in the death of the GBM patient.GBM histologically appears to be a tumor of vascular origin characterized by necrosis and microvascular proliferation, and neoangiogenesis is a key factor in the growth and poor prognosis of GBM. Therefore, inhibition of neoangiogenesis has received increasing attention from researchers as an important potential therapeutic target for GBM. Bevacizumab specifically binds to VEGF (mainly to VEGF-A), attenuates or prevents VEGF from binding to VEGFR-1 and VEGFR-2 on the surface of vascular endothelial cells, and blocks VEGFR-mediated downstream signaling pathways, inhibiting their biological activities, reducing tumor neovascularization and limiting tumor growth. Based on this background, the aim of this study was to evaluate the efficacy and safety of bevacizumab in the preoperative adjuvant treatment of patients with new-onset high-grade gliomas.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junkuan Wang, M.D.; Phone Number: 15036177557; Email: wjkuan@sina.cn

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • The first affiliated hospital of Zhengzhou university
      • Contact: Junkuan Wang, M.D.; Phone Number: 15036177557; Email: wjkuan@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Male or female.
• Imaging diagnosis of high-grade glioma.
• KPS score ≥60.

Exclusion Criteria:

• Prior treatment with anti-angiogenic targeted drugs;
• Comorbid serious cardiac, pulmonary, hepatic, or renal disease;
• History of an arterial/venous thrombotic event within 6 months prior to screening;
• Combination of infectious diseases such as tuberculosis and viral hepatitis;
• Comorbid infectious diseases such as tuberculosis, viral hepatitis, uncontrolled high blood pressure, bleeding disorders, and long-standing unhealed wounds or incompletely healed fractures;
• Patients with a history of psychotropic substance abuse that cannot be stopped or patients with mental disorders;
• Abnormal coagulation function, with bleeding tendency
• Patients who, in the opinion of the investigator, are not suitable for inclusion in the study (e.g., pregnant and lactating women).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bevacizumab group; Patients were enrolled and given bevacizumab on days 1 and 15, administered by intravenous infusion at 5 mg/kg.	Drug: Bevacizumab; Patients were enrolled and given bevacizumab on days 1 and 15, administered by intravenous infusion at 5 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defied as the percentage of subject with complete response (CR) or partial response (PR) by investigator assessment per REclsT criteria, version 1.1.	up to approximately 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	PFS is defned as the time from randomization untlthe date of first occurence of investigator assessed radiolbgical disease progression or death due to any cause,whichever came first.	up to approximately 2 years.
Overall survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause.	up to approximately 2 years.
Adverse event (AE) rates	AE assessed by NCI-CTCAE V5.0.	up to approximately 2 years.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Investigators: Principal Investigator: Junkuan Wang, M.D., The first affiliated hospital of Zhengzhou university

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Antineoplastic Agents, Immunological; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: QLMA-GBM-IIT-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No