Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501718
Status:
RECRUITING
Last Update Posted:
2023-04-19
First Post:
2020-08-04
Brief Title:
Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children
Sponsor:
Beijing Sanbo Brain Hospital
Organization:
Beijing Sanbo Brain Hospital
Study Overview
Official Title:
A Single Arm Clinical Phase Ⅱ Study of Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This research plan is implemented in accordance with GCP principles in Sanbo Brain Hospital of Capital Medical University
Subjects are screened into the group If the following conditions do not occur the subject withdraws the informed consent the drug side effects are intolerable the investigator thinks it is not suitable for further testing etc the expected research treatment for each subject It will continue until tumor progression or death confirmed by imaging studies but not more than 2 years Observe the effectiveness index and safety index during the test
Subjects are screened into the group If the following conditions do not occur the subject withdraws the informed consent the drug side effects are intolerable the investigator thinks it is not suitable for further testing etc the expected research treatment for each subject It will continue until tumor progression or death confirmed by imaging studies but not more than 2 years Observe the effectiveness index and safety index during the test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None