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New treatment option for Recurrent Atypical/malignant Meningioma
Official title Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults
ClinicalTrials.gov ID: NCT04501705
What this study is testing
What is Apatinib Mesylate?
Apatinib Mesylate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for recurrent atypical/malignant meningioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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)...
- Previous surgery and radiotherapy (including conventional radiotherapy or stereotactic radiosurgery treatment) are required. There are no...
- The time interval from the last radiotherapy is ≥4 weeks.
You likely can't join if
- Past application of anti-tumor angiogenesis drugs;
- Patients diagnosed with neurofibromatosis type 2 and other tumor syndromes;
- 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...
- 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 hypertension who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure ≤ 140 mmHg...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- Past application of anti-tumor angiogenesis drugs;
- Patients diagnosed with neurofibromatosis type 2 and other tumor syndromes;
- 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;
- 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;
- Patients with hypertension who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg);
- Patients with coronary heart disease ≥2 grade, arrhythmia (including QTc prolongation in men\>450 ms, women\>470 ms) and cardiac insufficiency;
- Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;
- Abnormal coagulation function (INR\>1.5 or prothrombin time (PT)\>ULN+4 seconds or APTT\>1.5×ULN), have bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
- There are many factors that affect the absorption of oral drugs, such as uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction;
- There is an infection that is difficult to control;
- Those who had significant blood coughing up 2 months before enrollment, or had blood volume of 2.5ml or more per day; had clinically significant bleeding symptoms or had clear bleeding tendency within 3 months before...
- Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis...
- Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;
- Other situations that the researcher thinks are not suitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.