Clinical Trial

NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer

Active, Not Recruiting Phase 2
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Summary
This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2019-06-28; most recent amendment 2026-01-23.
Status change: Recruiting → Active, Not Recruiting 2026-01-23
Status change: Not Yet Recruiting → Recruiting 2019-09-04
Trial Details
NCT Number NCT04005339
Lead Sponsor Georgetown University
Collaborators: Ipsen
Conditions Advanced Biliary Tract Cancer
Enrollment 48 participants
Start Date 2019-07-29
Primary Completion 2025-09-03 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-26