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Trial Summary

Protocol No.2018-0877
Principal InvestigatorTurk, Anita
PhasePhase II
Age GroupAdult
TitlePhase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer (NAPOLI-2)
DescriptionThis 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.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic.
  • No more than 1 prior line of chemotherapy for unresectable or metastatic disease (adjuvant therapy does not count).
For a full list of participation criteria, please visit
Applicable Disease SitesLiver
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632