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Exploratory study of bevacizumab neoadjuvant therapy for new high-grade brain gliomas

Exploratory study of bevacizumab neoadjuvant therapy for new high-grade brain gliomas

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087799
Enrollment
Unknown
Registered
2024-08-05
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-grade brain glioma

Interventions

treatment group:Patients were given bevacizumab by intravenous infusion at 5mg/kg on days 1 and 15 after enrollment, and MRI examination was performed before each administration

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over; 2. Male or female; 3. Imaging diagnosis of high-grade glioma; 4. KPS >= 60 points; 5. Good functioning of major organs, meeting the following requirements (excluding the use of any blood components and cell growth factors within 14 days prior to the first dose) : Routine blood tests: hemoglobin >= 90 g/L (no transfusion within 14 days); Neutrophil count > 1.5×10^9 /L; Platelet count >= 75×10^9 /L; Biochemical examination: total bilirubin = 60 ml/min (Cockcroft-Gault formula); Serum albumin >= 30g/dL; No life-threatening electrolyte abnormalities; 6. Good compliance, family members agree to cooperate with survival follow-up; 7. Patient informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received anti-angiogenesis targeted drug therapy; 2. Severe heart, lung, liver and kidney disease; 3. Arteriovenous thrombosis events occurred within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization during previous chemotherapy and determined to have recovered by investigators), and pulmonary embolism; 4. Combined with infectious diseases such as tuberculosis, viral hepatitis, etc. 5. Combination of uncontrolled hypertension, bleeding disorders, and long-term unhealed wounds or incomplete healing fractures; 6. Patients with a history of psychotropic substance abuse who are unable to abstain or have mental disorders; 7. Patients with abnormal coagulation function and bleeding tendency (14 days before enrollment must meet: INR within the normal range without the use of anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs; Prophylactic use of low-dose warfarin (1 mg poqd) or low-dose aspirin (up to 100 mg daily) is permitted if INR <=1.5; Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 8. A concomitant disease that, in the investigator's judgment, seriously endangers the patient's safety or interferes with the patient's ability to complete the study; 9. Patients considered unsuitable for inclusion in the study (such as pregnant or lactating women).

Design outcomes

Primary

MeasureTime frame
objective remission rate;

Secondary

MeasureTime frame
Total surgical resection rate;progression free survival;overall survival;safety;

Countries

China

Contacts

Public ContactWang Junkuan

The First Affiliated Hospital of Zhengzhou University

wjkuan@sina.cn+86 150 3617 7557

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026