Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572813
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Bortezomib Combined With PD-1 mAb and mFOLFIRINOX for Metastatic Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bortezomib Combined With PD-1 mAb and mFOLFIRINOX for First-line Treatment of Metastatic Pancreatic CancerAn Exploratory Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CISPD-7
Brief Summary:
This is an single-center prospective open-label clinical trial to explore the safty and efficacy of combination of Bortezomib Sindilizumab and mFOLFIRINOX Chemotherapy oxaliplatin fluorouracil irinotecan leucovorin in metastatic pancreatic cancer
Detailed Description:
Phase 1 Evaluation of Drug Tolerance Primary objective To evaluate the tolerability of bortezomib PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer and to determine the dose of bortezomib in the combination regimen Secondary objectives To evaluate the immunogenicity characteristics and safety of the combination regimen of bortezomib PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer Phase 2 Dose Expansion Primary objective To evaluate the tolerability and efficacy of the combination regimen of bortezomib PD-1 mAb and mFOLFIRINOX in patients with advanced metastatic pancreatic cancer Secondary Objective ORR PFS OS and to evaluate the immunogenicity and safety of bortezomib PD-1 mAb and mFOLFIRINOX in subjects with advanced metastatic pancreatic cancer and to explore biomarkers related to combination therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None