Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467565
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-15
Brief Title:
NALIRIFOX as Induction 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:
A Phase II Study of Liposomal Irinotecan Nal-IRI With 5 Fluorouracil Leucovorin and Oxaliplatin NALIRIFOX in Patients With Locally Advanced Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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 NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer
Detailed Description:
Subjects will be treated with the NALIRIFOX regimen every 2 weeks in 4-weeks cycles Imaging of tumor lesions will be performed after the subject has completed the first 2 cycles of treatment and if the subject has not progressed the subject will continue treatment until surgical resection disease progression RECIST 11 or intolerable toxicity start of new anticancer drug therapy withdrawal from the study death or loss to follow-up All treated subjects will be evaluated for response while on this treatment every 8 weeks 7 days after until surgical resection disease progression RECIST 11 intolerable toxicity start of new anticancer drug therapy withdrawal from the study death or loss to follow-up After 24 weeks of treatment capecitabine or S-1 is the maintenance regimen Radiographic response will be evaluated every 12 weeks 7 days during the maintenance phase
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