Brain metastases
Conditions
Interventions
experimental group:Apatinib combined with whole brain radiotherapy
Sponsors
Department of Oncology, The Second People's Hospital of Yibin
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, unlimited for men and women; 2. In patients with pathologically confirmed malignant tumors and brain metastases (> 3), head enhancement CT has at least one measurable focus, accompanied by at least one moderate and severe peritumoral edema. The edema is graded by EI value. EI is calculated as EI = (edema + tumor volume) / tumor volume. When EI = 1, there is no edema; when EI = 1-1.5, there is slight edema; when EI = 1.5-3, there is moderate edema When EI > 3, severe edema; 3. Karnofsky performance status (KPS score) >= 60; estimated survival time > 3 months. 4. Routine laboratory tests showed that bilirubin = 80% of the normal range. WBC >= 3.5 x 10^9 / L, ANC >= 1.5 x 10^9 / L, hemoglobin >= 90g / L, PLT >= 75 x 10^9 / L. 5. If the patient has a history of epileptic attack, anti epileptic treatment should be carried out and stable for 1 week. 6. For patients, surgery is unnecessary or high-risk, and they are not willing to have surgery. 7. Patients who are willing to join the study voluntarily, sign informed consent, have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have been confirmed to be allergic to apatinib and / or its excipients; 2. Pregnant or lactating women; 3. Patients with small cell lung cancer and brain metastasis; 4. In the first 3 months of the group, there were significant bleeding symptoms or definite bleeding tendency, gastrointestinal bleeding, bleeding gastric ulcer, occult blood of stool in baseline period and above, or vasculitis, etc; 5. Patients with abnormal clotting function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN) who have bleeding tendency or are undergoing thrombolysis or anticoagulation; patients who are treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; Note: on the premise that the international standard ratio of prothrombin time (INR) is less than or equal to 1.5, it is allowed to use low-dose heparin (6000-12000 u daily for adults) or aspirin (less than or equal to 100 mg daily) for prevention purposes; 6. Patients with known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, etc.); 7. Patients with major operation history and trauma history within 28 days. 8. Patients with long-term incurable wounds or fractures; 9. Patients with uncontrollable hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite the best drug treatment); 10. Patients with brain metastasis and peritumoral edema of lung squamous cell carcinoma with central type or cavity involving main blood vessels. 11. Patients with urinary protein >= + + and 24-hour urinary protein quantity > 1.0 g were confirmed by routine urine examination; 12. Patients considered unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of edema volume and edema index around the tumor; | — |
Secondary
| Measure | Time frame |
|---|---|
| kamofsky performance status;Average daily dose of dexamethasone and mannitol;Objective response rate;Disease control rate;intracranial progression-free survival;Total survival; | — |
Countries
China
Contacts
Public ContactWang Shanbing
The Second People's Hospital of Yibin
Outcome results
None listed