New hope for bile duct cancer: targeted chemo combo shows promise in early trial

NCT ID NCT04005339

Ongoing Disease control Sponsor: Georgetown University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 study is testing a combination of three drugs—nanoliposomal irinotecan, fluorouracil, and leucovorin—in 48 adults with advanced biliary tract cancer that has progressed after initial chemotherapy. The main goal is to see if the treatment can stop the cancer from growing for at least 4 months. The study is active but no longer recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: nanoliposomal irinotecan combined with fluorouracil and leucovorin
What this could lead to: If successful, this could offer a new second-line treatment option for people with advanced biliary tract cancer whose disease has worsened after initial chemotherapy.
What could go wrong: This is a small, early-phase (Phase 2) study with only 48 participants, so results may not apply to everyone. The drug combination may cause side effects and may not improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms cholangiocarcinoma digestive system neoplasm gallbladder adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED BILIARY TRACT CANCER

Contacts and locations

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, 10128, United States
Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States
Washington University School of Medicine- Siteman Cancer Center

St Louis, Missouri, 63110, United States

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