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Adding a liposomal chemotherapy did not help in second-line bile duct cancer, contradicting an earlier Korean trial.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
100 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival | nal-IRI + 5-FU/LV | - | 6.9 months | - | - | - |
| 5-FU/LV | - | 8.2 months |
This is the paper Europe PMC returns for registry id NCT03043547 with the most citations, so it is the natural first reading for anyone following the NALIRICC trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
A positive randomised phase 2 that the German NALIRICC trial failed to reproduce; guidelines list the regimen as an option, and the disagreement is a reminder that single-country phase 2 results in biliary cancer need replication.
Shares Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer, Cytotoxic chemotherapy and the tag failure.
Shares Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer, Cytotoxic chemotherapy and the tag failure.
Shares Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer and the tag failure.
Shares AIO (Arbeitsgemeinschaft Internistische Onkologie), Liposomal irinotecan, Leucovorin (folinic acid), Biliary tract cancer (all types).
Shares Liposomal irinotecan, Leucovorin (folinic acid), Biliary tract cancer (all types), Fluorouracil (5-FU).
Shares Liposomal irinotecan, Leucovorin (folinic acid), Biliary tract cancer (all types), Fluorouracil (5-FU).
Shares Liposomal irinotecan, Biliary tract cancer (all types), Fluorouracil (5-FU), Biliary tract cancer (cholangiocarcinoma).
Shares Liposomal irinotecan, Biliary tract cancer (all types), Fluorouracil (5-FU), Biliary tract cancer (cholangiocarcinoma).