Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Sanbo Brain Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Apatinib Mesylate
DrugApatinib mesylate tablets: Orally, 500 mg, once a day, with warm water for half an hour after a meal (the time of taking the medicine every day should be the same as possible). Continue to use 28 days as a cycle, medication until disease progression (PD), intolerable toxicity occurs or the patient withdraws informed consent. However, the longest period does not exceed 24 cycles, and the treatment after 24 cycles is determined by the investigator.
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: test groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS-6 %
6-month progression-free survival
Time frame
6-month progression-free survivalSecondary outcomes
1
ORR
Objective Response Rate
Time frame
up to 5 years2
OS
Overall survival
Time frame
up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov