malignant brain Metastases with peritumoral edema after radiotherapy
Conditions
Interventions
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects were willing to join in this study and sign the informed consent; 2. Aged 18 to 75 years; 3. ECOG score=2; 4. Histological diagnosed malignancy with brain metastasis. After radiotherapy of brain metastasis, there is at least one measurable lesion with moderate and severe peritumoral brain edema (PTBE) evalated by brain MRI. PTBE is graded by EI. EI= Volume of PTBE+tumor/Volume of tumor. EI=1, no edema; EI=1-1.5, mild PTBE; EI=1.5-3, moderate PTBE; EI>3, severe PTBE; 5. Before the application of apatinib, examination should meet the following criteria: (1) the blood routine examination must be in accordance with standard: 1) HB=90 g/L; 2) ANC=1.5×10^9/L; 3) PLT=80×10^9/L; (2) the biochemical examination must be in accordance with the following criteria: 1) TBIL=1.5×ULN; 2) ALT and AST=2.5×ULN; if has liver metastasis ALT and AST=5×ULN; 3) Serum Cr=1.25×ULN the endogenous creatinine clearance>45 ml/min (Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: Patients with any of the following may not be included in this study: 1. Patients who have previously used the apatinib; 2. Patients who have previously used targeted drug therapy of vascular endothelial growth inhibitors 3. The patient has a history of other malignant tumors, but has been cured except cervical carcinoma in situ,non melanoma skin cancer and superficial bladder tumor in the past five years; 4. 4 weeks prior to the start of the study involved in other drug clinical trial; 5. There are many factors that influence oral medication(such as unable to swallow, chronic diarrhea and intestinal obstruction); 6. has a bleeding history, 4 weeks prior to the start of the study has any bleeding event which reached 3 degrees or more according to CTCAE4.0; 7. Have high blood pressure and the antihypertensive drug treatment can't obtain good control (systolic blood pressure > 140 mmHg, diastolic blood pressure >90mmHg); 8. have no less than level-II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia (including QT interval=450 ms in male or 470ms in female) 9. Grade III-IV congestive heart failure (New York Heart Association (NYHA) classification)or LVEF 1.5 or prothrombin time (PT) > ULN 4 seconds or APTT >1.5 ULN), bleeding tendency or undergoing thrombolysis or anticoagulant therapy; anticoagulant or vitamin K antagonists such as warfarin, heparin or similar drugs for the treatment of patients; 11. Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulopathy); 12. Has a wound or fracture that has not healed for a long time; 13. Major surgical procedures or severe traumatic injuries, fractures or ulcers were performed within 4 weeks before randomization; 14. Routine urinary protein>++ and 24 hours urinary protein quantitative>1.0 g; 15. Have the history of psychotropic drugs abuse and can not give up or have mental disorders; 16. A history of immune deficiency, or has other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 17. According to the researcher's judgment, there are serious diseases that endanger the patient's safety or influence the clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate of malignant brain metastases;Resolution of peritumoral edema as shown by imaging; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom remission; | — |
Countries
China
Contacts
Public ContactMin Liu
The First Hospital of Jilin University
Outcome results
None listed