glioma
Conditions
Interventions
Case series:Patients were treated with temozolomide combined with apatinib
Sponsors
Sanbo Brain Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old, male or female; 2. With supratentorial space occupying, glioblastoma was initially diagnosed by pathology after biopsy or surgery; 3. The time intervals between completion of radiotherapy and enrollment were at least 3 months; 4. The interval form the last chemotherapy to the study enrollment was at least 4 weeks with resolution of all acute toxic effects to grade =1; 5. Confirmed by MRI that the tumor has a definite recurrence, 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 by another biopsy or surgery as recurrence pathologically; 6. The last surgery should have been completed at least 2 weeks before enrollment; 7. KPS=50; 8. life expectancy of at least 12 weeks; 9. If the patient is on glucocorticoid therapy, hormone dosage should be stable or decreased at least 5 days before baseline MRI. 10. The patient has no dysfunction of major organs, and the specific test indexes require that the leucocyte is greater than or equal to 3.0 x 10^9/L, platelet is greater than or equal to 75 x 109/L, hemoglobin is greater than or equal to 10g/dl, and serum bilirubin is not greater than 1.5 times of the maximum normal value.ALT and AST were not more than twice the maximum normal values. Creatinine is less than or equal to 1.5mg/dl; 11. Able to understand and willing to sign informed consent;Ability and willingness to follow study and follow-up procedures; 12. Both men and women at the gestational age must agree to take adequate contraceptive measures throughout the study period.
Exclusion criteria
Exclusion criteria: 1. previous treatment with bevacizumab or other antiangiogetic drugs; 2. Patients previously use enzyme-inducing antiepileptic drugs (EIAED) must be switched to non-EIAED at least 2 weeks before enrollment; 3. 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 patients with carcinoma in situ; 4. Patients with hypertension who cannot be reduced to normal range by antihypertensive drug therapy (systolic blood pressure 450ms in men, > 470ms in women) and cardiac insufficiency with grade 2 or higher; 6. Urine routine indicated that urine protein was greater than or equal to (++), or urine protein was greater than or equal to 1.0g at 24 hours; 7. Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 * ULN), with bleeding tendency or receiving thrombolytic or anticoagulant treatment; 8. It has a variety of factors affecting oral drug absorption, such as nausea and vomiting, chronic diarrhea and intestinal obstruction; 9. There were clinically significant bleeding symptoms or clear bleeding tendency in the first 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, baseline fecal occult blood ++ and above, intracranial or intracranial hemorrhage, or vasculitis; 10. 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.; 11. Women who are pregnant or breast-feeding;Patients with fertility are unwilling or unable to take effective contraceptive measures; 12. Other conditions considered inappropriate by the researcher for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactJun-ping Zhang
Sanbo Brain Hospital, Capital Medical University
Outcome results
None listed