Recurrent glioblastoma
Conditions
Interventions
Sponsors
Fudan University Huashan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Within 2 weeks before treatment, KPS>=60; 3. Complete resection or partial resection of the tumor at the initial treatment, with clear pathological diagnosis; 4. Patients with recurrence of glioblastoma after standard postoperative radiotherapy and chemotherapy; 5. The end of the first radiotherapy >=6 months; 6. Expected survival >=3 months; 7. The main organs function well, and the examination indexes meet the following requirements; 8. Blood routine examination: Hemoglobin >=90 g/L (no blood transfusion within 14 days); Neutrophil count >=1.5x10^9/L; Platelet count >=80x10^9/L; 9. Biochemical examination: Total bilirubin =50 ml/min (Cockcroft-Gault formula); 10. Sign the informed consent; 11. Good compliance, family members agreed to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Having other malignant tumors at the same time, except those malignant tumors that have been cured or have stable disease; 2. The primary lesion was located in the brainstem, or the maximum diameter of postoperative residual lesion was more than 5cm; 3. Spinal MR or CEREBROspinal fluid examination showed evidence of spinal diffusion; 4. Received other glioma related treatments except surgery, radiotherapy and chemotherapy at the initial treatment; 5. Reoperation was performed before reradiotherapy, except for biopsy; 6. Pregnant or lactating women; 7. Participated in other clinical trials within one month; 8. There are multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and ileus); 9. Any bleeding event with severe grade 3 or above CTCAE5.0 occurred within 4 weeks prior to screening; 10. Patients with hypertension and unable to obtain good control after single antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure b> 90 mmHg); A history of unstable angina pectoris;Screening for newly diagnosed angina within 3 months or myocardial infarction within 6 months prior to screening;Arrhythmias (including QTcF: male >=450 ms) require long-term use of antiarrhythmic drugs and New York Heart Association grade >=II cardiac dysfunction; 11. Long-term unhealed wound or incomplete fracture; 12. Has a history of organ transplantation; 13. Imaging showed that the tumor had invaded important blood vessels or that the patient's tumor was highly likely to invade important blood vessels during the treatment, resulting in fatal massive bleeding; 14. Patients with abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L) and bleeding tendency (14 days before randomization, INR must be within the normal range without the use of anticoagulant);Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs;Low-dose warfarin (1 mg oral, qD) or low-dose aspirin (not more than 100 mg daily) is permitted for prophylactic purposes as long as the international standard ratio of prothrombin time (INR) <=1.5; 15. Screening for the occurrence of ARTERiovenous thrombosis (AVT) in the previous year, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization due to previous chemotherapy, which has been determined to be cured by the researcher), and pulmonary embolism; 16. Has a history of substance abuse and is unable to quit or has a mental disorder; 17. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 18. Concomitant diseases that, according to the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study; 19. Patients who did not meet the inclusion criteria or were considered unfit to enter the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Objective remission rate (ORR);Quality of live (QOLS);Cognitive function score;Adverse effects (AE); | — |
Countries
China
Contacts
Public ContactZhirui Zhou
Fudan University Huashan Hospital
Outcome results
None listed