RecruitingPhase 2NCT06467565

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

20 participants

Start Date

Dec 25, 2023

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing NALIRIFOX — a four-drug chemotherapy combination — as an initial treatment before surgery for locally advanced pancreatic cancer (cancer that has grown into nearby blood vessels or structures but has not spread to distant organs). **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with locally advanced pancreatic ductal adenocarcinoma confirmed by biopsy - You have not yet had surgery, chemotherapy, targeted therapy, or radiation for this cancer - You are in good health (ECOG 0-1) **You may NOT be eligible if...** - Your cancer has already spread to distant parts of your body (metastatic) - You have had prior treatment for pancreatic cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiposomal 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.