# NALIRICC (AIO)

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

## TL;DR

Adding a liposomal chemotherapy did not help in second-line bile duct cancer, contradicting an earlier Korean trial.

## Summary

NALIRICC, run by the German AIO group and published in Lancet Gastroenterology and Hepatology in 2024, found that adding liposomal irinotecan to fluorouracil and leucovorin did not help in second-line biliary tract cancer after gemcitabine, contradicting the earlier positive Korean NIFTY trial. It was a phase 2 of 100 patients that showed no improvement in progression-free or overall survival, although a 2025 pooled analysis of the two trials modestly favoured the combination. OnCo links it to biliary tract cancer and cytotoxic chemotherapy, and notes that second-line FOLFOX, per ABC-06, gives a small benefit. Whether the discordance between the two trials reflects population differences or chance is the open question.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-07
- Tags: failure; lesson:replication
- Registry id: NCT03043547
- Phase: 2
- Setting: Second-line biliary tract cancer after gemcitabine: liposomal irinotecan + 5-FU/LV vs 5-FU/LV
- Sponsor: AIO (Germany)
- Enrolled: 100
- Result: OS 6.9 vs 8.2 months; not improved.
- Outcomes: Overall survival: nal-IRI + 5-FU/LV 6.9 months vs 5-FU/LV 8.2 months

## Notes

- Gallbladder cancer: NALIRICC (AIO, NCT03043547) enrolled biliary tract cancer including gallbladder carcinoma after gemcitabine-based therapy; it is the negative counterpart of NIFTY and the reason liposomal irinotecan remains an option rather than a standard in second line.

## Sources

- Lancet Gastroenterol Hepatol 2024: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00119-5/fulltext

## 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/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Liposomal irinotecan](https://onco.cc/drugs/liposomal-irinotecan/)
- companies: [AIO (Arbeitsgemeinschaft Internistische Onkologie)](https://onco.cc/companies/aio/)
- key papers: [Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study](https://onco.cc/key-papers/paper-nifty-liposomal-irinotecan-lancet-oncol-2021/), [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](https://onco.cc/key-papers/paper-naliricc-lancet-gastroenterol-hepatol-2024/)
- trials: [NIFTY](https://onco.cc/trials/nifty/)
- roadmaps: [Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials](https://onco.cc/roadmaps/gallbladder-cancer-roadmap/)

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