Glioma
Conditions
Interventions
TTF+BEV+chemotherapy :Continue to receive Optune treatment for an average of = 18h/d, 28d is one cycle, a total of 12 cycles, BEV 5mg/Kg,chemotherapy
TTF+chemotherapy:Continue to receive Optune treatment for an average of = 18h/d, 28d is one cycle, a total of 12 cycles, chemotherapy
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. GBM was confirmed by histological examination (WHO classification IV); Recurrent GBM patients confirmed after standard treatment (surgery and stupp regimen); 2. There are evaluable tumor lesions according to RANO standard; 3. The number of recurrences shall not exceed 2; 4. supratentorial tumor; 5. Age = 18 years old and = 70 years old at the time of enrollment, regardless of gender; 6. KPS score = 60 points; 7. Subjects have not received bevacizumab or tumor treatment electric field treatment in the past; 8. The ratio of urine protein to creatinine (UPC) within 14 days before the subjects were enrolled in the group was less than 1.0 or proteinuria test paper was less than 2+; 9. Subjects have completed 4 weeks after glioma resection or 7 days after stereotactic biopsy before enrollment; 10. Subjects did not receive radiotherapy within 90 days before enrollment; 11. Subjects have recovered from the toxic effects of previous treatment before enrollment, and the specific time is as follows: A. 28 days after the administration of any investigational drug; B. 28 days after the administration of cytotoxic drugs, except: 28 days after the administration of vincristine or irinotecan; Nitrosourea was administered for 42 days; Methylbenzylhydrazine was administered for 21 days; 12. The subjects fully understand the benefits and risks of the trial, are still willing to participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The expected survival period is less than 3 months; 2. Subjects who cannot accept MRI examination; 3. Other electronic devices implanted in the brain such as cardiac pacemaker, defibrillator or deep brain stimulator; 4. Subjects had heart failure, acute myocardial infarction, persistent and clinically significant arrhythmia within 6 months before admission; 5. Subjects had cerebrovascular accident (CVA) and transient ischemic attack (TIA) within 6 months before enrollment; 6. Subjects had pulmonary embolism (PE) within 6 months before enrollment; 7. After treatment with antihypertensive drugs, systolic blood pressure>140mmHg and diastolic blood pressure>90mmHg in hypertensive subjects; 8. The subject has severe liver disease, and Child-Pugh grade is B or C; 9. Subjects with respiratory diseases such as COPD need hospitalization or cannot accept research treatment; 10. Subjects are allergic to bevacizumab or cannot receive bevacizumab treatment for other reasons; 11. Subjects are seriously allergic to conductive hydrogel; 12. Within 7 days before enrollment, the laboratory test results of the subjects met any one of the following: A. Blood routine test: absolute number of neutrophils 1.5 × ULNALT>2.5 × ULNAST>2.5 × ULN; C. Renal function: blood creatinine > 1.5 × ULN, creatinine clearance2+or>1 g/L; 13. Subjects have a history of abuse or drug abuse of psychotropic substances; 14. Subjects with HBsAg or HBcAb positive and HBV DNA titer in peripheral blood = 1 × 103IU/mL; Subjects who cannot accept MRI examination; 15. The subjects were positive for HCV, Treponema pallidum antibody or HIV antibody; 16. Subjects participated in other clinical trials within 1 month before enrollment; 17. Subjects had severe trauma or infectious diseases within 4 weeks before enrollment; 18. The results of blood pregnancy test of female subjects during non-lactation and within 7 days before the first study treatment were positive. Subjects (male and female) refused to promise to use at least one acceptable contraceptive measure (i.e. intrauterine device, condom, any form of hormone contraceptive or abstinence) during the whole study period and within 3 months after the last treatment in the study; 19. The investigator decided that it was not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progress Free Survival; | — |
Countries
China
Contacts
Public ContactXun Kang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed