Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345300
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-28
Brief Title:
NALIRIFOX in Combination With Camrelizumab for BRPC a Prospective Exploratory Study
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Liposomal IrinotecanOxaliplatin 5-FluorouracilCalcium Folinate in Combination With Camrelizumab for Borderline Resectable Pancreatic Cancer a Prospective Exploratory Study
Status:
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:
The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan Oxaliplatin 5-FluorouracilCalcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer
Detailed Description:
This study plans to include 40 patients with borderline resectable pancreatic cancer who are evaluated by a multidisciplinary team MDT These patients will receive 3 cycles of neoadjuvant therapy before surgery The immunotherapy combination chemotherapy regimen consists of liposomal Irinotecan Oxaliplatin 5-FluorouracilCalcium folinate and Camrelizumab with a 14-day dosing cycle The chemotherapy regimen consists of liposomal Irinotecan Oxaliplatin and 5-FluorouracilCalcium folinate
Clinical tumor imaging evaluation will be conducted based on the RECIST 11 criteria after the completion of neoadjuvant therapy The MDT will assess whether patients are eligible for surgery based on the imaging results The criteria for operability include no evidence of implantation metastasis during laparoscopic exploration absence of new metastatic lesions and the tumors relationship with blood vessels meeting the criteria for R0R1 resection
Patients eligible for surgery will undergo pancreatic cancer surgery 4-6 weeks later Postoperative treatment will be determined by the researchers based on the neoadjuvant treatment effectiveness and the patientsactual conditions Imaging evaluations will follow the standard diagnostic and treatment guidelines for pancreatic cancer
For patients deemed ineligible for surgery the subsequent treatment plan will be determined by the researchers based on the neoadjuvant treatment effectiveness and the patients actual conditions
Clinical tumor imaging evaluation will be conducted based on the RECIST 11 criteria after the completion of neoadjuvant therapy The MDT will assess whether patients are eligible for surgery based on the imaging results The criteria for operability include no evidence of implantation metastasis during laparoscopic exploration absence of new metastatic lesions and the tumors relationship with blood vessels meeting the criteria for R0R1 resection
Patients eligible for surgery will undergo pancreatic cancer surgery 4-6 weeks later Postoperative treatment will be determined by the researchers based on the neoadjuvant treatment effectiveness and the patientsactual conditions Imaging evaluations will follow the standard diagnostic and treatment guidelines for pancreatic cancer
For patients deemed ineligible for surgery the subsequent treatment plan will be determined by the researchers based on the neoadjuvant treatment effectiveness and the patients actual conditions
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