Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06259058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-06
Brief Title:
Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer a Phase IbII Multicenter Open-label Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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 open-label trial will compare the efficacy and safety of stereotactic body radiation therapy SBRT followed by NALIRIFOX 5-fluorouracil leucovorin irinotecan liposome injection and oxaliplatin vs NALIRIFOX for borderline resectable pancreatic cancer BRPC
Detailed Description:
Neoadjuvant chemotherapy or chemoradiotherapy can increase the R0 resection rate and improve survival in BRPC However there is no standard treatment regimen The National Comprehensive Cancer Network NCCN guidelines recommend FOLFIRINOX irinotecan oxaliplatin 5-FULV and FOLFIRINOX chemoradiotherapy for PDAC neoadjuvant treatment
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
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