Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06210360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2024-01-02
Brief Title:
Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
NALIRIFOX as Perioperative Treatment in Patients With High-risk Resectable Pancreatic Cancer a Multicenter Randomized Open-label 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 multicentric randomized trial will compare the efficacy and safety of neoadjuvant chemotherapy surgery adjuvant chemotherapy or surgery adjuvant chemotherapy in patients with high-risk resectable pancreatic cancer NALIRIFOX 5-fluorouracil leucovorin irinotecan liposome injection and oxaliplatin will be used as the chemotherapy regimen
Detailed Description:
Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan It adopts a special loading technology to encapsulate traditional irinotecan in liposomes which can avoid its hydrolysis under physiological conditions increase the affinity with cancer cells overcome drug resistance increase the drug uptake by cancer cells reduce the drug doseimprove the efficacy and reduce the toxic side effects The aim of this study is to compare the efficacy and safety of NALIRIFOX surgery NALIRIFOX or surgery NALIRIFOX in high-risk patients with resectable 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