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

Sponsor
Beijing Sanbo Brain Hospital
Study ID
NCT04501718
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Medulloblastoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 28, 2020
Status verified
Oct 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Test group

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 4 years ]

Central Contacts

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