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

Overview

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.

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.

Interventions

• Drug Bevacizumab
  Patients were enrolled and given bevacizumab on days 1 and 15, administered by intravenous infusion at 5 mg/kg.

Primary outcome measures

• Objective response rate (ORR) [Time frame: up to approximately 2 years.]

Secondary outcome measures (3)

• Progression-free survival (PFS) [Time frame: up to approximately 2 years.]
• Overall survival (OS) [Time frame: up to approximately 2 years.]
• Adverse event (AE) rates [Time frame: up to approximately 2 years.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou

Identifiers

NCT: NCT06747728 · QLMA-GBM-IIT-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗