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

NCT06747728 | Recruiting

• 1 other identifier: QLMA-GBM-IIT-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression-free survival (PFS)

  up to approximately 2 years.

• Overall survival (OS)

  up to approximately 2 years.

• Adverse event (AE) rates

  up to approximately 2 years.

Study Arms (1)

Bevacizumab group

EXPERIMENTAL

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

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

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

Bevacizumab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Junkuan Wang, M.D.

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junkuan Wang, M.D.

CONTACT

15036177557; wjkuan@sina.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Bevacizumab

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)