Recurrent glioblastoma
Conditions
Interventions
Group 1:Apatinib combined with temozolamide for treatment
Group 2:The patients were treated with temozolomide
Sponsors
Sanbo Brain Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old, male or female; 2. Primary supratentorial glioblastoma was pathologically diagnosed after first biopsy or resection; 3. Radiotherapy after surgery was needed, and the time interval between the last radiotherapy and enrollment is no less than 3 months; 4. No more than 1 chemotherapy regimen was accepted, and the time interval from the last chemotherapy was no less than 4 weeks; 5. Recurrence was confirmed by MRI, the diameter of the enhanced lesion is greater than or equal to 1cm, greater than or equal to 2 layers (the interval between layers is 5mm), or confirmed pathologically after another biopsy or surgery; 6. The interval from the last biopsy or surgery should be no less than 2 weeks; 7. KPS score should be at least 60%; 8. If the patient is on glucocorticoid therapy, hormone dosage should be stable or decreased at least 5 days prior to baseline MRI; 9. Life expectancy is no less than 12 weeks; 10. The main organs function is normal, without serious blood, heart, lung, liver, kidney function abnormalities or immunodeficiency diseases.Laboratory inspection meets the following requirements: (1) blood routine examination should be in line with (no blood transfusion within 14 days): HGB 110 g/L or higher; the WBC acuity 3.0 x 10^9/L; NEUT acuity 1.5 x 10^9/L; PLT acuity 75 x 10^9 / L; (2) biochemical examination should meet the following standards: A. BIL is less than or equal to 1.5 times upper limit of normal value (ULN); B. ALT and AST are less than or equal to 2.0 times ULN; C. Serum Cr less than or equal to 1.5 x ULN or endogenous creatinine clearance rate greater than or equal to 50ml/min (Cockcroft-Gault formula); (3) fecal occult blood (-); (4) normal urine routine, or urine protein <(++), or 24 hours of urine protein < 1.0g; (5) LVEF should be greater than 50%; 11. Normal coagulation function, no active bleeding and thrombosis: (1) The international standardized ratio INR is less than or equal to 1.5 x ULN; (2) APTT is less than or equal to 1.5 x ULN; (3) PT is less than or equal to 1.5uln; 12. Women of child-bearing age shall undergo a pregnancy test (serum or urine) with negative results within 7 days prior to enrollment and shall voluntarily use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of apatinib mesylate tablets; For men, surgical sterilization or consent to appropriate contraceptive methods should be given during the observation period and within 8 weeks of the last administration of apatinib mesylate tablets; 13. Provide 25-30 slides of tumor tissue of the last biopsy or surgery; 14. Patients volunteered to participate in the study and signed an informed consent form (ICF); 15. Good compliance is expected, and efficacy and adverse reactions can be followed up as required by the program.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with anti-angiogenic drugs; 2. Persons who are known to be allergic to apatinib mesylate in any composition; 3. Receiving enzyme-inducing antiepileptic drugs (EIAEDs), unless the drugs have been replaced with non-EIAEDs for at least 2 weeks away from enrollment; 4. Patients with other malignant tumors, unless they have lived without progression for 5 years and the researchers believe that the risk of recurrence is low or the tumor is carcinoma in situ; 5. Patients with hypertension who cannot be reduced to normal by antihypertensive drug therapy (systolic blood pressure 450ms in men, > 470ms in women) and cardiac insufficiency with grade 2 or higher; 7. Urine routine indicated that urine protein was greater than or equal to (++), or urine protein was greater than or equal to 1.0g within 24 hours; 8. Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 x ULN), with bleeding tendency or receiving thrombolytic or anticoagulant treatment; 9. Has a variety of factors affecting oral drug absorption, such as nausea and vomiting, chronic diarrhea and intestinal obstruction; 10. There were clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, baseline fecal occult blood ++ or above, intracranial or intracranial hemorrhage, or vasculitis; 11. Arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 12. Women who are pregnant or breast-feeding;Patients with fertility are unwilling or unable to take effective contraceptive measures; 13. Other conditions considered by the researchers to be inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS-6%; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival;disease control rate;objective response rate;Evaluation of quality of life;Maintenance time of KPS=70;Glucocorticoid use; | — |
Countries
China
Contacts
Public ContactJun-ping Zhang
Sanbo Brain Hospital, Capital Medical University
Outcome results
None listed