glioblastoma
Conditions
Interventions
Low dose bevacizumab:Bevaczumab 5mg/kg q2w
Standard dose bevacizumab:Bevaczumab 10mg/kg q2w
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Previously diagnosed with glioblastoma, reoperated after recurrence, histologically confirmed as glioblastoma (WHO grade IV); 2. Previously confirmed histologically as glioblastoma (WHO grade IV), this recurrence was unable to obtain tissue again due to various reasons, but imaging confirmed recurrence GBM, and other reasons such as false progression and possibility of radiation necrosis were excluded; 3. Has not previously received anti VEGF drugs or nitrosourea treatment; 4. The confirmed age is greater than 18 years old; 5. Symptoms of intracranial hypertension can be controlled after dehydration treatment, and medication can be continued to maintain stability during enrollment or during the study period. 6. According to the Eastern Oncology Collaborative Group (ECOG) standard, the physical fitness score is 0 or 1; 7. Expected survival time = 3 months; 8. Good hematopoietic function (no blood transfusion or erythropoietin dependence within 7 days): HGB = 90g/L, WBC = 3.0 × 10 ^ 9/L, NEUT = 1.5 × 10 ^ 9/L, PLT = 75 × 10 ^ 9/L; 9. Good liver function is defined as the upper limit of normal value (ULN) with a total bilirubin level = 1.5 times; Upper limit of normal values (ULN) for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels = 2.5 times 10. Good renal function is defined as the upper limit of normal value (ULN) with serum creatinine = 1.5 times or endogenous creatinine clearance rate = 50ml/min; Urinary routine examination shows that urine protein is less than 2+. If the patient's baseline urine protein is = 2+, 24-hour urine should be collected and it should be demonstrated that the 24-hour urine protein quantitative detection is = 1g; 11. Normal coagulation function, no active bleeding or thrombotic disease. ULN with an international standardized ratio INR = 1.5 times; ULN with partial thromboplastin time APTT = 1.5 times; ULN with prothrombin time PT = 1.5 times; If the patient is receiving anticoagulant therapy, as long as PT is used within the prescribed range of anticoagulant drugs 12. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the medication period and within 3 months after the medication ends; Patients who have negative serum or urine pregnancy tests within 7 days prior to study enrollment and must be non lactating patients should agree to use contraception during the study period and within 3 months after the end of the study period; 13. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up 14. Sign a written informed consent form before implementing any experimental related processes
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypertension (systolic blood pressure>150 mm Hg or diastolic blood pressure>100 mm Hg), and arterial or venous thrombosis 6 months before surgery; 2. Pregnant or lactating women; 3. Having a history of allergy or allergic constitution to VEGF monoclonal antibodies; 4. There was arterial or venous thrombosis 6 months before enrollment, and there was evidence of recent bleeding on brain MRI; 5. Severe heart disease (such as a history of myocardial infarction or unstable angina within the first 6 months of inclusion), or the use of therapeutic doses of oral or parenteral anticoagulants or thrombolytic drugs. 6. Serious other accompanying diseases that cannot be treated; 7. Known history of abuse, alcoholism, and drug use of psychotropic substances; 8. KPS score<60, intolerant to anti-tumor therapy; 9. Engaging or expected to participate in other clinical studies. 10. Researchers believe that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall response rate;side effects rate; | — |
Countries
China
Contacts
Public ContactShasha Du
Guangdong Provincial People's Hospital
Outcome results
None listed