Clinical trial NCT06747728: Bevacizumab Neoadjuvant Therapy for New High-grade Gliomas in the Brain
Official title: Bevacizumab Neoadjuvant Therapy for New High-grade Gliomas in the Brain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Glioma
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Bevacizumab
Primary purpose: TREATMENT

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.

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.

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).

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to approximately 2 years.
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to approximately 2 years.
measure: Overall survival (OS)
timeFrame: up to approximately 2 years.
measure: Adverse event (AE) rates
timeFrame: up to approximately 2 years.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Junkuan Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: