About this trial
This study is a prospective single-center clinical study, which aims to observe and evaluate the efficacy and safety of apatinib combined with temozolomide and oral etoposide in the treatment of recurrent medulloblastoma in children.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 2-21 (at the time of diagnosis), no gender limit.
After biopsy or surgery, the first postoperative pathological diagnosis is medulloblastoma.
The recurrence of the tumor is confirmed by MRI, that is, the diameter of the lesion on the enhanced MRI image is ≥1cm, and ≥2 slices (slice spacing 5mm) are visible; or after another biopsy or surgery, the pathological diagnosis is medulloblastoma.
The time interval from the last radiotherapy is ≥4 weeks.
Disqualifiers
Past application of anti-tumor angiogenesis drugs;
Those who are known to be allergic to any component of temozolomide, apatinib, and etoposide;
Are using antiepileptic drugs that induce liver drug enzymes, unless they have been replaced with antiepileptic drugs that are non-hepatic drug enzymes at least 2 weeks away from enrollment;
Patients with other malignant tumors, unless they have survived without progression for 5 years and the researcher believes that the risk of recurrence is low or patients with carcinoma in situ;
Trial design
Single group
Treatments tested in this trial
Apatinib Combined With Temozolomide and Etoposide Capsules
DrugApatinib mesylate tablets: Oral, 250mg, qd. Take the medicine with warm water half an hour after a meal (the daily medicine should be taken at the same time as possible). 28 days is a cycle, and the medication is administered until the disease progresses (PD), intolerable toxicity occurs or the patient withdraws informed consent. The longest period does not exceed 12 cycles. The treatment after 12 cycles is determined by the investigator.
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate (ORR)
Progression-free survival (PFS)
Overall survival (OS)
Sponsors and contacts
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