Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-21
SponsorBeijing Sanbo Brain Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Apatinib Combined With Temozolomide and Etoposide Capsules

    Drug

    Apatinib 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

44 Participants
are divided into 1 treatment group
Group A: Test groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Time frame
up to 4 years
2

Progression-free survival (PFS)

Time frame
up to 4 years
3

Overall survival (OS)

Time frame
up to 4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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