🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-01-23)

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

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Georgetown University

🩺 Protocol 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.

Primary Research Facility: Lombardi Comprehensive Cancer Center, Georgetown University (Washington D.C., District of Columbia)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Advanced Biliary Tract Cancer?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 18 Years or older?

🔍 Protocol Specified Minimum Age: 18 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 4 Registered Participating Sites

📍 Primary Site Map

Site: Lombardi Comprehensive Cancer Center, Georgetown University — Washington D.C., District of Columbia

📍 All Participating Trial Locations (4 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Lombardi Comprehensive Cancer Center, Georgetown University — Washington D.C., District of Columbia

2. Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana

3. Washington University School of Medicine- Siteman Cancer Center — St Louis, Missouri

4. Icahn School of Medicine at Mount Sinai — New York, New York

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT04005339 • Last Synced: 2026-01-23

View on ClinicalTrials.gov ↗