Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer

Summary

AIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II trial

Timeline

Start

2018-01-24

Primary completion

2022-01-01

Completion

2025-01-31

Outcome

Met primary endpoint

paper The NIFE trial formally met its primary end point with a 4-month PFS rate of 51% in patients receiving nal-IRI/FU/LV. PMID 38843469 ↗

Publications

• Ettrich TJ, Modest DP, Sinn M, Striefler JK, Opitz B, Goetze T, Gallmeier E, Angermeier S, Fischer von Weikersthal L, Jacobasch L, Waldschmidt D, Niedermeier M, Sohm M, Berger AW, Manzini G, Fehrenbach U, Auer TA, Hosse C, Vogele D, Sookthai D, Schaaf M, Muche R, Hinke A, Seufferlein T, Perkhofer L. Nanoliposomal Irinotecan With Fluorouracil and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Cholangiocarcinoma: A Phase II Study of the AIO Hepatobiliary-YMO Cancer Groups (NIFE-AIO-YMO HEP-0315). J Clin Oncol. 2024 Sep 10;42(26):3094-3104. doi: 10.1200/JCO.23.01566. Epub 2024 Jun 6.
• Perkhofer L, Berger AW, Beutel AK, Gallmeier E, Angermeier S, Fischer von Weikersthal L, Goetze TO, Muche R, Seufferlein T, Ettrich TJ. Nal-IRI with 5-fluorouracil (5-FU) and leucovorin or gemcitabine plus cisplatin in advanced biliary tract cancer - the NIFE trial (AIO-YMO HEP-0315) an open label, non-comparative, randomized, multicenter phase II study. BMC Cancer. 2019 Oct 23;19(1):990. doi: 10.1186/s12885-019-6142-y.

Drugs

Indications