Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690231
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2020-12-26
Brief Title:
Apatinib Ifosfamide and Etoposide for Relapsed or Refractory Osteosarcoma
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
ApatinibIfosfamide and Etoposide IE Versus IE Alone for Relapsed or Refractory Osteosarcoma a Real-world Study in Two Centers in China
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Today using a multi-modal approach consisting of preoperative neoadjuvant systemic polychemotherapy followed by local surgical therapy and then postoperative adjuvant chemotherapy long-term disease-free survival can be achieved in 60- 70 of osteosarcoma patients However treatment options for osteosarcomas especially in the setting of metastatic or unresectable disease are very scarce Apatinib has been proved to be an effective agent to prolong progression-free survival in advanced osteosarcoma But after 4-6 months treatment secondary resistance always occurred with musculoskeletal lesions progression or new metastasis
Nowadays giving therapeutic doses of IE concurrently with anti-angiogenesis tyrosine kinase inhibitors is a conceptually attractive strategy for treating patients with refractory osteosarcoma according to prospective trial of lenvatinib IE reported by Gaspar et al at 2019 ESMO and 2020 ESMO Thus This study was designed to review our experience in real world for off-label use and characterize the toxicity profile of concurrent apatinibIE and IE alone in patients with relapsed or refractory osteosarcoma
Nowadays giving therapeutic doses of IE concurrently with anti-angiogenesis tyrosine kinase inhibitors is a conceptually attractive strategy for treating patients with refractory osteosarcoma according to prospective trial of lenvatinib IE reported by Gaspar et al at 2019 ESMO and 2020 ESMO Thus This study was designed to review our experience in real world for off-label use and characterize the toxicity profile of concurrent apatinibIE and IE alone in patients with relapsed or refractory osteosarcoma
Detailed Description:
None
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