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Recruiting Not applicable

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

NCT06747728 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-03-01
Last updated
2024-12-24

Condition(s) studied

Brain Glioma

Investigational drug(s) / intervention(s)

Bevacizumab →

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Objective response rate (ORR) — 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.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06747728 on ClinicalTrials.gov ↗ ← All trials in China