NCT06210360

Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

NALIRIFOX as Perioperative Treatment in Patients With High-risk Resectable Pancreatic Cancer : a Multicenter, Randomized, Open-label Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicentric randomized trial will compare the efficacy and safety of neoadjuvant chemotherapy + surgery + adjuvant chemotherapy or surgery + adjuvant chemotherapy in patients with high-risk resectable pancreatic cancer. NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) will be used as the chemotherapy regimen.

Detailed description

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 dose,improve 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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan liposome injection	50 mg/m² on Day 1 of a 14 day cycle
DRUG	Oxaliplatin	60 mg/m² on Day 1 of a 14 day cycle
DRUG	5-FU	2400 mg/m² continuous IV infusion in 46 h
DRUG	LV	400 mg/m² on Day 1 of a 14 day cycle

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-04-01
• Completion: 2027-04-01
• First posted: 2024-01-18
• Last updated: 2024-01-18