Biliary tract cancer (BTC) has a high mortality. Primary diagnosis is frequently delayed due to mostly unspecific symptoms, resulting in a high number of advanced cases at the time of diagnosis. Advanced BTCs are in principle chemotherapy sensitive as determined by improved disease control, survival and quality of life (QoL). | 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 noncomparative randomized multicenter phase II study