# NIFE (AIO-YMO HEP-0315)

Source: https://onco.cc/trials/nife/  
OnCo record `nife` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The German NIFE trial gave liposomal irinotecan with fluorouracil as a first treatment for bile duct and gallbladder cancer alongside a standard gemcitabine and cisplatin arm, each judged on its own by the share of patients free of progression at four months. It completed with 93 patients.

## Summary

NIFE (NCT03044587) was an interventional, prospective, randomised, open-label two-sided phase 2 designed with a Simon two-stage design in each arm: nal-IRI 80 mg/m², fluorouracil 2,400 mg/m² and leucovorin 400 mg/m² every 14 days (arm A) versus cisplatin 25 mg/m² and gemcitabine 1,000 mg/m² days 1 and 8 every 21 days (arm B), analysed unconnected. Randomisation was stratified by tumour site (intrahepatic versus extrahepatic biliary tract), stage, age, sex and performance status. The primary endpoint was the progression-free survival rate at four months in each arm, with overall progression-free survival, three-year survival, disease control at two months, safety and quality of life as secondary endpoints. The registry records 93 patients enrolled at German sites, primary completion in January 2022 and study completion in January 2025. A primary results paper was not found in Europe PMC in September 2026; only the protocol is indexed. It sits between NIFTY (positive, second line) and NALIRICC (negative, second line) in the liposomal irinotecan story.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-24
- Also known as: NIFE
- Registry id: NCT03044587
- Phase: 2
- Setting: First-line advanced biliary tract cancer: liposomal irinotecan with fluorouracil and leucovorin (arm A) or gemcitabine and cisplatin (arm B), open-label non-comparative randomised phase 2
- Sponsor: AIO-Studien-gGmbH
- Enrolled: 93

## Sources

- ClinicalTrials.gov NCT03044587: https://clinicaltrials.gov/study/NCT03044587
- Perkhofer et al., BMC Cancer 2019: NIFE protocol: https://doi.org/10.1186/s12885-019-6142-y

## Connected records

- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Gemcitabine + cisplatin](https://onco.cc/drugs/gemcitabine-cisplatin/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Liposomal irinotecan](https://onco.cc/drugs/liposomal-irinotecan/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)

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