Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387810
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-04-22
Brief Title:
Irinotecan Liposome II in Combination With 5-FULV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Irinotecan Liposome II in Combination With 5-FULV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic CancerA Prospective Single-arm Multicenter Phase II Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
undetermined
Brief Summary:
This is a prospective single-arm phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FULV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients
Detailed Description:
This is a prospective single-arm phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FULV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients
After screening and signing informed consent patients who met the admission requirements received neoadjuvant therapy with irinotecan liposome II combined with 5-FULV and oxaliplatin before surgery once every 2 weeks every 2 weeks After completing 4 cycles of preoperative neoadjuvant therapy surgical evaluation was performed
For patients evaluated for radical surgical resection surgery was performed within 2 to 4 weeks after the end of neoadjuvant therapy abdominal enhanced CTMRI was performed within 4 to 6 weeks after surgery and postoperative adjuvant therapy with irinotecan liposome II combined with 5-FULV and oxaliplatin was performed according to the investigators judgment once every 2 weeks a 2-week cycle After the completion of 4 cycles of postoperative adjuvant therapy the tumor progression follow-upsurvival follow-up stage was entered
Patients who were assessed as not eligible for radical surgical resection could choose follow-up treatment according to the investigators judgment and continue to follow up their survival until withdrawal of informed consent or death
After screening and signing informed consent patients who met the admission requirements received neoadjuvant therapy with irinotecan liposome II combined with 5-FULV and oxaliplatin before surgery once every 2 weeks every 2 weeks After completing 4 cycles of preoperative neoadjuvant therapy surgical evaluation was performed
For patients evaluated for radical surgical resection surgery was performed within 2 to 4 weeks after the end of neoadjuvant therapy abdominal enhanced CTMRI was performed within 4 to 6 weeks after surgery and postoperative adjuvant therapy with irinotecan liposome II combined with 5-FULV and oxaliplatin was performed according to the investigators judgment once every 2 weeks a 2-week cycle After the completion of 4 cycles of postoperative adjuvant therapy the tumor progression follow-upsurvival follow-up stage was entered
Patients who were assessed as not eligible for radical surgical resection could choose follow-up treatment according to the investigators judgment and continue to follow up their survival until withdrawal of informed consent or death
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