Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 8:54 AM
Study NCT ID:
NCT05926492
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Osteosarcoma
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Non-randomized Controlled Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Patients With Osteosarcoma
Status:
RECRUITING
Status Verified Date:
2023-06
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 phase II study aims to explore the tumor necrosis rate in osteosarcoma patients treated with a neoadjuvant regimen of surufatinib combined with chemotherapy.
Detailed Description:
Surufatinib is a potent inhibitor of colony-stimulating factor 1 receptor（CSF-1R）, which shows a promising tumor inhibition effect on sarcoma. This is a prospective, multicenter, controlled phase II study to explore the efficacy and safety of surufatinib combined with chemotherapy in neoadjuvant treatment of osteosarcoma. In this study, 160 patients were enrolled into the following treatment groups with a 1:1 ratio: (1) Surufatinib + chemotherapy group (N=80) (2) control group: chemotherapy group (N=80); A 30-day treatment cycle was performed, the efficacy was evaluated after 2 cycles of neoadjuvant therapy. The primary endpoints were tumor necrosis rate, and secondary endpoints were 1-year progression-free survival (PFS) and drug safety.
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?: