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

NCT ID NCT04005339

First seen Jan 29, 2026 · Last updated Jun 23, 2026 · Updated 27 times

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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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.

Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms digestive system neoplasm

As listed by the trial registrant

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