Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365008
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer a Prospective Single-arm Phase II Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy However there are no standard recommendations for subsequent treatment after progression on first-line therapy Here the investigators conduct this open-label monocenter single arm phase II study to evaluate whether sintilimab in combination with irinotecan leucovorin folinate and fluorouracil can be the salvage therapy for patients diagnosed with unresectable or metastatic gastric cancer progression on first-line therapy Patients participated in this study will receive sintilimab 3mgkg for patients with body weight60kg or 200mg for patients with body weight 60kg plus irinotecan 180mgm2 intravenous infusion leucovorin folinate 400mgm2 intravenous infusion and fluorouracil 400mgm2 intravenous injection followed by 2400mgm2 intravenous infusion for 48 hours repeated every two weeks The primary endpoint is progression-free survival PFS The investigators estimated that 40 patients were necessary Secondary endpoints include overall survival objective response rate disease control rate and safety for unresectable or metastatic gastric cancer
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