NALIRIFOX as Induction Therapy in LAPC

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

• NCT number: NCT06467565
• Study type: Interventional
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Rong K Jiang, MD
• Phone: +8615312995688
• Email: jiangkuirong@njmu.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: December 25, 2023
• Completion date: December 31, 2025