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NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study

Borderline Resectable Pancreatic Cancer Clinical Trial

Official title:
Liposomal Irinotecan，Oxaliplatin, 5-Fluorouracil/Calcium Folinate in Combination With Camrelizumab for Borderline Resectable Pancreatic Cancer: a Prospective, Exploratory Study

Clinical Trial Summary

The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer

Clinical Trial 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-Fluorouracil/Calcium folinate, and Camrelizumab, with a 14-day dosing cycle. The chemotherapy regimen consists of liposomal Irinotecan, Oxaliplatin, and 5-Fluorouracil/Calcium folinate. Clinical tumor imaging evaluation will be conducted based on the RECIST 1.1 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 tumor's relationship with blood vessels meeting the criteria for R0/R1 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 patients'actual 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06345300
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Yongkun Sun
Phone 13141276041
Email hsunyk@126.com
Status Recruiting
Phase Phase 2
Start date March 10, 2024
Completion date December 24, 2025
View Details
See also
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