sentence: 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 )
paragraph: 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 ) 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). However, median OS does not exceed 11.7 months with the current standard of care gemcitabine plus cisplatin. Thereby, novel drug formulations like nanoliposomal-irinotecan (nal-IRI) in combination with 5- fluorouracil (5-FU)/leucovorin may have the potential to improve therapeutic outcomes in this disease. ### methods NIFE is an interventional, prospective, randomized, controlled, open label, two-sided phase II study. Within the study, 2 × 46 patients with locally advanced, non-resectable or metastatic BTC are to be enrolled by two stage design of Simon. Data analysis will be done unconnected for both arms. Patients are allocated in two arms: Arm A (experimental intervention) nal-IRI mg/m ### discussion The NIFE trial evaluates the potential of a nanoliposomal-irinotecan/5-FU/leucovorin combination in the first line therapy of advanced BTCs and additionally offers a unique chance for translational research. ### Trial Registration Clinicaltrials.gov NCT03044587. Registration Date February 7th 2017.