Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475326
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Adebrelimab in Combination With NALIRIFOX in Locally Advanced Pancreatic Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Phase II Trial of Adebrelimab in Combination With NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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:
In this study Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy followed by different treatment methods such as surgery continued conversion therapy and advanced systemic therapy according to different transformation outcomes to improve the survival benefit of subjects with locally advanced pancreatic cancer
Detailed Description:
In this study Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy followed by different treatment methods such as surgery continued conversion therapy and advanced systemic therapy according to different transformation outcomes to improve the survival benefit of subjects with locally advanced pancreatic cancer
To assess the surgical resection conversion rate of chemotherapy in addition to immunotherapy for unresectable locally advanced pancreatic cancer LAPC
To evaluate the changes in CA19-9 levels objective response rate ORR R0R1 resection rate pathologic response pCRMPR event-free survival EFS 1 year and 2 years and overall survival 1y-OS 2y-OS OS before and after conversion therapy for unresectable locally advanced pancreatic cancer
To assess perioperative safety including surgical morbidity and mortality within 60 days To evaluate the safety and tolerability of immunotherapy in combination with chemotherapy for conversion therapy for unresectable locally advanced pancreatic cancer
To assess the surgical resection conversion rate of chemotherapy in addition to immunotherapy for unresectable locally advanced pancreatic cancer LAPC
To evaluate the changes in CA19-9 levels objective response rate ORR R0R1 resection rate pathologic response pCRMPR event-free survival EFS 1 year and 2 years and overall survival 1y-OS 2y-OS OS before and after conversion therapy for unresectable locally advanced pancreatic cancer
To assess perioperative safety including surgical morbidity and mortality within 60 days To evaluate the safety and tolerability of immunotherapy in combination with chemotherapy for conversion therapy for unresectable locally advanced pancreatic cancer
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