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

Source: https://onco.cc/trials/nct04005339/  
OnCo record `nct04005339` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of fluorouracil, leucovorin and liposomal irinotecan in gallbladder cancer and other biliary tract cancers, run by Georgetown University, active and no longer recruiting.

## Summary

NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer is a phase 2 interventional study registered as NCT04005339 by Georgetown University, with a registry enrolment figure of 48 participants, started 2019-07-29 and due to reach its primary completion in 2025-09-03. Interventions recorded: Nanoliposomal Irinotecan, Leucovorin, Fluorouracil. Conditions listed: Advanced Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: "* Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic". Sites: United States. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Tags: ctgov-ingest; gallbladder-deep-dive
- Registry id: NCT04005339
- Phase: 2
- Setting: NAPOLI-2: Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer
- Sponsor: Georgetown University
- Enrolled: 48

## Sources

- ClinicalTrials.gov NCT04005339: https://clinicaltrials.gov/study/NCT04005339

## Connected records

- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Liposomal irinotecan](https://onco.cc/drugs/liposomal-irinotecan/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)

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