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NCT Number: NCT06747728

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location status: Recruiting

Location contact

Junkuan Wang, M.D.

CONTACT

[email protected]

15036177557

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bevacizumab

Drug

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

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: up to approximately 2 years.

    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.

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: up to approximately 2 years.

    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.

  2. Overall survival (OS)

    Time frame: up to approximately 2 years.

    OS is defined as the time from the date of randomization to the date of death due to any cause.

  3. Adverse event (AE) rates

    Time frame: up to approximately 2 years.

    AE assessed by NCI-CTCAE V5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Junkuan Wang, M.D.

CONTACT

[email protected]

15036177557

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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