Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-11-23
Brief Title:
Cadonilimab Plus mFOLFIRINOX as Conversion Therapy in LAPC
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Cadonilimab Plus mFOLFIRINOX as Conversion Therapy in Patients With Locally Advanced Pancreatic CancerA Prospective Single-arm Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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 prospective single arm single center phase II study of cadonilimab plus mFOLFIRINOX as conversion therapy in patients with locally advanced pancreatic cancer
Detailed Description:
Eligible patients with histologicallycytologically confirmed unresectable locally advanced pancreatic cancer LAPC will receive cadonilimab 6mgkgIVDD1Q2W plus mFOLFIRINOX oxaliplatin 85mgm2 D2 leucovorin 400mgm2 D2 irinotecan 150mgm2 D2 5-fluorouracil 2400mgm2 46h continuous infusion for 4 cycles 8 weeks
After completing every 4 treatment cycles the subjects will undergo imaging examinations of tumor lesions If the subjects do not experience disease progression they will continue to receive treatment until surgical resection disease progression RECIST 11 or intolerable toxic reactions occur new anticancer drug treatment begins withdrawal from the study death or loss of follow-up All subjects who have received treatment are required to undergo efficacy evaluation every 8 weeks 7 days after the start of treatment until disease progression or study termination After the 12th cycle of treatment the maintenance treatment plan is to use capecitabine or S-1 combined with cadonilimab for maintenance treatment During maintenance treatment imaging efficacy evaluation is conducted every 12 weeks 7 days and surgical resectability is still evaluated until surgical resection disease progression RECIST 11 or intolerable toxic reactions occur new anticancer drug treatment begins withdrawal from the study death or loss of follow-up
After completing every 4 treatment cycles the subjects will undergo imaging examinations of tumor lesions If the subjects do not experience disease progression they will continue to receive treatment until surgical resection disease progression RECIST 11 or intolerable toxic reactions occur new anticancer drug treatment begins withdrawal from the study death or loss of follow-up All subjects who have received treatment are required to undergo efficacy evaluation every 8 weeks 7 days after the start of treatment until disease progression or study termination After the 12th cycle of treatment the maintenance treatment plan is to use capecitabine or S-1 combined with cadonilimab for maintenance treatment During maintenance treatment imaging efficacy evaluation is conducted every 12 weeks 7 days and surgical resectability is still evaluated until surgical resection disease progression RECIST 11 or intolerable toxic reactions occur new anticancer drug treatment begins withdrawal from the study death or loss of follow-up
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