Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies

Summary

is an open label, randomized, multicenter phase II trial

Timeline

Start

2017-10-24

Primary completion

2021-12-08

Completion

2022-03-08

Publications

• Yoo C, Saborowski A, Hyung J, Wenzel P, Kim I, Wege H, Kim KP, Folprecht G, Ryoo BY, Schutt P, Cheon J, Gotze T, Ryu H, Lee JS, Vogel A. Liposomal irinotecan for previously treated patients with biliary tract cancer: A pooled analysis of NIFTY and NALIRICC trials. J Hepatol. 2025 Oct;83(4):909-916. doi: 10.1016/j.jhep.2025.03.013. Epub 2025 Mar 25.
• Vogel A, Saborowski A, Wenzel P, Wege H, Folprecht G, Kretzschmar A, Schutt P, Jacobasch L, Ziegenhagen N, Boeck S, Zhang D, Kanzler S, Belle S, Mohm J, Gokkurt E, Lerchenmuller C, Graeven U, Pink D, Gotze T, Kirstein MM. Nanoliposomal irinotecan and fluorouracil plus leucovorin versus fluorouracil plus leucovorin in patients with cholangiocarcinoma and gallbladder carcinoma previously treated with gemcitabine-based therapies (AIO NALIRICC): a multicentre, open-label, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Aug;9(8):734-744. doi: 10.1016/S2468-1253(24)00119-5. Epub 2024 Jun 10.

Drugs

Indications