NCT06345300

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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-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

Conditions

• Borderline Resectable Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab	The treatment regimen for this study is as follows: Intravenous infusion of Oxaliplatin at a dose of 85mg/m2 for 2 hours or according to clinical practice at the research center; Intravenous infusion of liposomal Irinotecan at a dose of 60mg/m2 for 90 minutes (±30 min); Intravenous drip of Calcium folinate at a dose of 400mg/m2 for 30 minutes or according to clinical practice at the research center; Intravenous infusion of 5-Fluorouracil at a dose of 2400mg/m2 (infused for 46-48 hours or according to clinical practice at the research center); Camrelizumab at a fixed dose of 200mg, administered via intravenous drip, with each infusion lasting no less than 30 min and no more than 60 min. Administered on day 1 of every 2-week cycle (d1, q2w). Each treatment cycle is 14 days, and all drugs are administered on day 1.
DRUG	Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate	The treatment regimen for this study is as follows: Intravenous infusion of Oxaliplatin at a dose of 85mg/m2 for 2 hours or according to clinical practice at the research center; Intravenous infusion of liposomal Irinotecan at a dose of 60mg/m2 for 90 minutes (±30 min); Intravenous drip of Calcium folinate at a dose of 400mg/m2 for 30 minutes or according to clinical practice at the research center; Intravenous infusion of 5-Fluorouracil at a dose of 2400mg/m2 (infused for 46-48 hours or according to clinical practice at the research center); Each treatment cycle is 14 days, and all drugs are administered on day 1.

Timeline

• Start date: 2024-03-10
• Primary completion: 2024-12-12
• Completion: 2025-12-24
• First posted: 2024-04-03
• Last updated: 2024-04-03

Locations

1 site across 1 country: China