Relapse high-grade glioma
Conditions
Interventions
AV-BEV Group:ccombined intravenous and intra-arterial delivery of bevacizumab
V-BEV Group:venous delivery of bevacizumab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who sign informed consent and are willing to complete the study according to the protocol; 2. Aged 18-70 years old male or female; 3. ECOG 0-2; 4. KPS >=60; 5. Patients with interval between the last operation >=2 weeks; 6. The patients who received radiotherapy after operation, the time interval between the last radiotherapy >=3 months, or the time interval =4 weeks or =110g/L; b) WBC>=3.0x10^9/L; NEUT>=1.5x10^9/L; c) PLT >=75x10^9/L; (2) Biochemical inspection must meet the following standards: 1) TBIL and DBIL =50ml/min (Cockcroft-Gault formula); (3) Occult blood (-); (4) Urine routine is normal, or urine protein =50%; (6) The coagulation function is normal, and there is no active bleeding and thrombosis. 1) International standardized ratio INR<=1.5 ULN; 2) Partial thromboplastin time APTT<=1.5 ULN; 3) Prothrombin time PT<=1.5 ULN; 12. Women of childbearing age and their families need to agree to effective contraception during the study; 13. Considering infertility and abnormal sperm, all men are recommended to use contraceptives and frozen sperm; 14. Have a previous history of cerebrovascular disease, especially cerebral aneurysms and cerebral arteriovenous malformations, which need to be treated and cured by DSA angiography without recurrence; 15. It is expected that those with good compliance will be able to follow up the curative effect and adverse reactions according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. With medical history of malignant tumors within 3 years before or after enrollment; 2. Cases with targeted drugs; 3. Patients with acute infection currently requiring intravenous antibiotics; 4. Patients diagnosed with human immunodeficiency virus infection or symptomatic acquired immunodeficiency syndrome; 5. Patients who are currently pregnant or breastfeeding; 6. With history of allergies to TMZ or other similar alkylating agents and allergies to bevacizumab; 7. Other conditions determined by the researcher to be poorly compliant or unable to complete the study; 8. People with previous history of hypertensive cerebral hemorrhage and acute cerebral infarction; 9. Patients who participated in another clinical trial within 30 days before the grouping and received the investigational drug and any concomitant treatment containing the investigational drug; 10. With severe heart, lung, liver and kidney dysfunction;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactYiqun Cao
Fudan university Shanghai Cancer Center
Outcome results
None listed