Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-27 @ 12:20 PM
Study NCT ID:
NCT05177068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2021-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conversion Therapy of Fruquintinib in Combination With Sintilimab and SOX in Unresectable Gastric Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Study Overview
Official Title:
A Phase II Clinical Study of Fruquintinib Combined With Sintilimab and SOX as Conversion Therapy of Potentially Resectable Stage IV Gastric Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
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 is a phase II study to evaluate the efficacy and safety of combination of fruquintinib (VEGFR 1/2/3 inhibitor), sintilimab (PD-1 inhibitor) and SOX conversion therapy in unresectable advanced gastric cancer patients.
Detailed Description:
Eligible patients will be given 3 or 6 cycles of combined therapy of fruquintinib + sintilimab + SOX. Then the patients evaluated resectable will be given one additional cycle of combined treatment with sintilimab + SOX, followed by R0 resection. If evaluated unresectable after 6 cycles of combination therapy, the patient will be given palliative first-line treatment. Adjuvant treatment with SOX regimen will be started 4 weeks after R0 resection for a total of 8 cycles in the perioperative period.
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?: