Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults (NCT04501705) | Clinical Trial Compass
RecruitingNot Applicable
Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults
China29 participantsStarted 2020-08-18
Plain-language summary
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.
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Age ā„18 years old (at the time of enrollment), regardless of gender.
ā. The pathological diagnosis of atypical/malignant meningioma was clear after biopsy or surgery.
ā. The tumor recurrence is confirmed by MRI, that is, the diameter of the lesion on the enhanced MRI image is ā„1cm, and ā„2 slices (slice interval 5mm) are visible; or after another biopsy or surgery, the pathological diagnosis is atypical/malignant meningioma.
ā. 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
ā. The time interval from the last radiotherapy is ā„4 weeks.
ā. The time interval from the last chemotherapy is ā„4 weeks, and the patients have fully recovered from the acute toxicity of the last treatment.
ā. The interval between the last biopsy or surgery is ā„2 weeks.
ā. KPS score ā„50 points.
Exclusion criteria
ā. Past application of anti-tumor angiogenesis drugs;
ā. Patients diagnosed with neurofibromatosis type 2 and other tumor syndromes;
ā. People who are known to be allergic to any component of apatinib mesylate;
. Antiepileptic drugs that induce liver enzymes are being used, unless antiepileptic drugs that have been replaced with non-hepatic enzymes are at least 2 weeks away from enrollment;
ā. Patients with other malignant tumors, unless they have survived for 5 years and the investigator believes that the risk of recurrence is low or patients with carcinoma in situ;
ā. Patients with hypertension who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure ā¤ 140 mmHg / diastolic blood pressure ā¤ 90 mmHg);
ā. Patients with coronary heart disease ā„2 grade, arrhythmia (including QTc prolongation in men\>450 ms, women\>470 ms) and cardiac insufficiency;
ā. Urine routine test indicates urine protein ā„(++), or 24-hour urine protein ā„1.0g;