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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу

Идентификаторы

NCT: NCT06747728 · QLMA-GBM-IIT-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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