high-grade glioma
Conditions
Interventions
experimental group:Apatinib Mesylate Tablets, Temodal
control group:Temodal
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years old; 2. Pathological diagnosis of high-grade (WHOIII, IV) glioma patients with recurrence; 3. Within 6 weeks after biopsy or surgery; 4. Have not received chemotherapy or radiotherapy; 5. There are measurable lesions on the head magnetic resonance; 6. ECOG score: 0-2 points; 7. Estimated survival time = 3 months; 8. No serious heart, lung, bone marrow dysfunction, no bleeding tendency, no history of cerebral embolism and cerebral hemorrhage, no history of severe hypertension, no serious postoperative complications (including intracranial hematoma, severe intracranial infection, etc.) 9. Subjects received damage from other treatments, including nitroso or mitomycin at intervals of = 6 weeks; other cytotoxic drugs, radiation or surgery = 4 weeks, and the wound has completely healed; 10. The main organs function normally, that is, they meet the following criteria: (1) Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli): HB=90 g/L; ANC = 1.5 × 10^9 / L; PLT = 80 × 10^9 / L; (2) Biochemical examinations must meet the following criteria: TBIL 45 ml/min (Cockcroft-Gault formula); 11. Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days prior to enrollment and the results were negative, and willing to use the appropriate method of contraception during the trial and 8 weeks after the last administration of the test drug. For men, consent must be given to the appropriate method of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the test drug; 12. Subjects volunteered to participate in the study and signed informed consent, with good adherence and follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating woman; 2. Those who suffer from high blood pressure and cannot be reduced to the normal range by antihypertensive drugs(Systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg). Have grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval = 440 ms) and grade II cardiac insufficiency; 3. Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 4. Abnormal blood coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; 5. Pulmonary hemorrhage =CTCAE level 2 occurred within 4 weeks before the first use of the study drug; bleeding occurred at other sites of =CTCAE level 3 within 4 weeks before the first use of the study drug; 6. Events of arteriovenous thrombosis occurring within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; 7. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues. Under the premise of prothrombin time international normalized ratio (INR) = 1.5, small doses of warfarin (1 mg orally, once daily) or low-dose aspirin (daily doses between 80 mg and 100 mg) are allowed for prophylactic purposes; 8. With serious heart, lung, bone marrow dysfunction, bleeding tendency, history of cerebral embolism and cerebral hemorrhage, history of severe hypertension, serious postoperative complications (including intracranial hematoma, severe intracranial infection, etc.); 9. The investigator determines other conditions that may affect the conduct of the clinical study and the determination of the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;DCR;ORR;QoL; | — |
Countries
China
Contacts
Public ContactXia He
Jiangsu Cancer Hospital
Outcome results
None listed