Actively Recruiting
Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults
Led by Beijing Sanbo Brain Hospital · Updated on 2024-10-15
29
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years at enrollment
- Confirmed pathological diagnosis of atypical or malignant meningioma by biopsy or surgery
- Tumor recurrence confirmed by MRI showing lesion diameter of at least 1 cm on 2 or more slices, or confirmed by biopsy or surgery
- Previous surgery and radiotherapy (including conventional or stereotactic radiosurgery) completed
- At least 4 weeks since last radiotherapy
- At least 4 weeks since last chemotherapy with full recovery from acute toxicity
- At least 2 weeks since last biopsy or surgery
- Karnofsky Performance Status (KPS) score of 50 or higher
- Stable or decreased glucocorticoid dose for at least 2 weeks before baseline MRI if on such therapy
- Expected survival time of at least 12 weeks
- Normal main organ functions without serious blood, heart, lung, liver, kidney dysfunction or immune deficiency
- Laboratory blood counts and biochemical tests within specified limits (no recent blood transfusion)
- Normal coagulation function without active bleeding or thrombosis
- Female participants of childbearing potential must have negative pregnancy test and use contraception during and 8 weeks after treatment; males must also use contraception
- Provide 25-30 tumor tissue slices from last biopsy or surgery
- Ability to swallow tablets intact
- Voluntary informed consent
- Willingness and ability to comply with study follow-up and assessments
You will not qualify if you...
- Previous use of anti-tumor angiogenesis drugs
- Diagnosis of neurofibromatosis type 2 or other tumor syndromes
- Known allergy to any component of apatinib mesylate
- Use of liver enzyme-inducing antiepileptic drugs within 2 weeks before enrollment unless switched to non-enzyme-inducing drugs
- Presence of other malignant tumors unless disease-free for 5 years or carcinoma in situ
- Uncontrolled hypertension despite antihypertensive treatment
- Moderate or severe coronary heart disease, arrhythmia, or cardiac insufficiency
- Urine protein levels of (++) or higher or 24-hour urine protein ≥1.0 g
- Abnormal coagulation function with bleeding risk or on anticoagulant/thrombolytic therapy
- Conditions affecting oral drug absorption such as uncontrollable nausea, vomiting, chronic diarrhea, or intestinal obstruction
- Difficult to control infections
- Significant blood coughing or bleeding episodes within specified recent time frames
- Arterial or venous thrombosis events within 6 months prior to enrollment
- Pregnant or breastfeeding women and those unwilling or unable to use effective contraception
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sanbo Brain Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Jun-ping Zhang, Chief Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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