High-grade brain glioma
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total surgical resection rate;progression free survival;overall survival;safety; | — |
Countries
China
Contacts
The First Affiliated Hospital of Zhengzhou University