NCI-2019-07694

Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer (NAPOLI-2)

This is a research study called NAPOLI-2. It is designed to see how well a specific treatment combination works for people with advanced biliary tract cancer (BTC) who have already been treated with other medications. The treatments used are: Fluorouracil (5-FU): This is a chemotherapy medication that works by interfering with the growth of cancer cells. Leucovorin (LV): This medication helps enhance the effects of 5-FU. Nanoliposomal irinotecan (nal-IRI): This is a type of medication that delivers the chemotherapy drug irinotecan directly to cancer cells. This study is phase II, open label and single arm.

Open-Label: Patients know which treatments are being given to them

Single arm: Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

Phase II: An advanced point of testing, where they're trying to confirm if a treatment works well.

Biliary Tract Cancer: This is a cancer that forms in the bile ducts, which are tubes that carry bile from the liver and gallbladder to the small intestine

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT04005339

NCI-2019-07694

Clinical Trial Site: Sinai

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