Clinical Study of Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults
Apatinib mesylate may be an effective treatment for recurrent atypical/malignant meningioma. This prospective clinical study is now planned to verify the effectiveness and safety of apatinib mesylate in the treatment of relapsed atypical/malignant meningioma.
• Age ≥18 years old (at the time of enrollment), regardless of gender.
• The pathological diagnosis of atypical/malignant meningioma was clear after biopsy or surgery.
• The tumor recurrence is confirmed by MRI, that is, the diameter of the lesion on the enhanced MRI image is ≥1cm, and ≥2 slices (slice interval 5mm) are visible; or after another biopsy or surgery, the pathological diagnosis is atypical/malignant meningioma.
• Previous surgery and radiotherapy (including conventional radiotherapy or stereotactic radiosurgery treatment) are required. There are no restrictions on whether to receive chemotherapy or the number of times of the above treatments
• The time interval from the last radiotherapy is ≥4 weeks.
• The time interval from the last chemotherapy is ≥4 weeks, and the patients have fully recovered from the acute toxicity of the last treatment.
• The interval between the last biopsy or surgery is ≥2 weeks.
• KPS score ≥50 points.
• If the patient is on glucocorticoid therapy, the hormone dosage has stabilized or decreased for at least 2 weeks before the baseline MRI.
⁃ The expected survival time is ≥12 weeks.
⁃ The main organ functions are normal, and there is no serious blood, heart, lung, liver, kidney dysfunction and immune deficiency diseases. The laboratory inspection meets the following requirements:
‣ (1) Routine blood examination, which must be met (no blood transfusion within 14 days):
• HGB≥100g/L;
• WBC≥3.0×109/L; NEUT≥1.5×109/L;
• PLT ≥100×109/L; (2) The biochemical inspection shall meet the following standards:
‣ a. BIL≤1.5 times the upper limit of normal (ULN); b. ALT and AST≤2.0×ULN; c. Serum Cr≤1.5×ULN or endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula); (3) Occult blood in stool (-); (4) Urine routine is normal, or urine protein \<(++), or 24-hour urine protein \<1.0 g; (5) Left ventricular ejection fraction (LVEF) ≥50%. 12. The coagulation function is normal, without active bleeding and thrombosis.
• International standardized ratio INR≤1.5×ULN;
• Partial thromboplastin time APTT≤1.5×ULN;
• Prothrombin time PT≤1.5ULN. 13. Female patients of childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of apatinib mesylate tablets ; Male patients of childbearing age should agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of apatinib mesylate tablets.
• 14\. Patients need to provide 25-30 pieces of tumor tissue slices after the last biopsy or surgery.
• 15\. The patient has normal swallowing function and can swallow the tablet intact.
• 16\. The patient voluntarily joined the study and signed an informed consent form (ICF).
• 17\. The patient is expected to have good compliance and be able to follow up the efficacy and adverse reactions as required by the protocol.