NCT06467565

NALIRIFOX as Induction Therapy in LAPC

A Phase II Study of Liposomal Irinotecan (Nal-IRI) With 5 Fluorouracil, Leucovorin, and Oxaliplatin (NALIRIFOX) in Patients With Locally Advanced Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer.

Detailed description

Subjects will be treated with the NALIRIFOX regimen every 2 weeks in 4-weeks cycles Imaging of tumor lesions will be performed after the subject has completed the first 2 cycles of treatment, and if the subject has not progressed, the subject will continue treatment until surgical resection, disease progression (RECIST 1.1) or intolerable toxicity, start of new anticancer drug therapy, withdrawal from the study, death, or loss to follow-up. All treated subjects will be evaluated for response while on this treatment every 8 weeks (±7) days after until surgical resection, disease progression (RECIST 1.1), intolerable toxicity, start of new anticancer drug therapy, withdrawal from the study, death, or loss to follow-up.. After 24 weeks of treatment, capecitabine or S-1 is the maintenance regimen. Radiographic response will be evaluated every 12 weeks (± 7 days) during the maintenance phase.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Liposomal irinotecan	NALIRIFOX（Oxaliplatin 60 mg/m2 IV over 2 hours ; Liposomal Irinotecan 50 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion） on days 1 of a 14-day cycle.

Timeline

• Start date: 2023-12-25
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

1 site across 1 country: China