New drug combo shows promise for Tough-to-Treat bile duct cancer

NCT ID NCT03044587

First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 36 times

Summary

This phase 2 trial tested a new chemotherapy combination (Nal-IRI with 5-FU and leucovorin) against a standard treatment (gemcitabine plus cisplatin) in 93 people with advanced biliary tract cancer that could not be removed by surgery. The study aimed to see which approach better controls tumor growth and improves survival. Results will help determine if this new combo deserves further study.

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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

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

What this could mean

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

Active substance

Nal-IRI (a chemotherapy drug) combined with 5-fluorouracil and leucovorin

What this could lead to

If successful, this could provide a new chemotherapy option for people with advanced biliary tract cancer who cannot have surgery.

What could go wrong

This is an early phase 2 trial with a small number of participants, so results may not confirm effectiveness. Chemotherapy can cause significant side effects.

Conditions

The condition(s) this trial relates to.

adenocarcinoma adenocarcinoma of gallbladder and extrahepatic biliary tract bile duct adenocarcinoma bile duct neoplasm biliary tract cancer Biliary Tract Neoplasms cholangiocarcinoma extrahepatic bile duct carcinoma hepatocellular carcinoma intrahepatic cholangiocarcinoma metastatic carcinoma

As listed by the trial registrant

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