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Randomized Phase II Trial of Fluorouracil and Folinic Acid With or Without Liposomal Irinotecan (ONIVYDE) for Patients With Metastatic Biliary Tract Cancer Which Progressed Following Gemcitabine Plus Cisplatin

Trial Profile

Randomized Phase II Trial of Fluorouracil and Folinic Acid With or Without Liposomal Irinotecan (ONIVYDE) for Patients With Metastatic Biliary Tract Cancer Which Progressed Following Gemcitabine Plus Cisplatin

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Fluorouracil (Primary) ; Folic acid (Primary) ; Irinotecan (Primary)
  • Indications Biliary cancer; Cholangiocarcinoma; Gallbladder cancer
  • Focus Therapeutic Use
  • Acronyms NIFTY
  • Most Recent Events

    • 24 Oct 2023 Results (n=278) assessing the individual patient data meta-analysis compared efficacy of second-line chemotherapy for advanced BTC after progression on GemCis, including the phase 2b NIFTY trial (NCT03524508) and the phase 2 FIReFOX trial (NCT03464968), presented at the 48th European Society for Medical Oncology Congress.
    • 13 Sep 2022 Final Results(n=174) assessing the efficacy of of liposomal Irinotecan plus fluorouracil /leucovorin in patients with previously treated metastatic biliary tract cancer presented at the 47th European Society for Medical Oncology Congress
    • 22 Aug 2022 Status changed from active, no longer recruiting to completed.
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