NALIRICC (AIO)
Adding a liposomal chemotherapy did not help in second-line bile duct cancer, contradicting an earlier Korean trial.
No PFS or OS improvement (OS 6.9 vs 8.2 months); the earlier NIFTY trial had been positive. Pooled analysis (2025) modestly favoured the combination. Second-line chemotherapy (FOLFOX per ABC-06) provides a small benefit.
Setting
Second-line biliary tract cancer after gemcitabine: liposomal irinotecan + 5-FU/LV vs 5-FU/LV
Phase
Phase 2
Sponsor
AIO (Germany)
Headline result
OS 6.9 vs 8.2 months; not improved.
Reported
2024
Enrolled
100
In plain words
What these results mean for people, not percentages
Overall survivalsurvival endpoint
- Median 6.9 vs 8.2 months with nal-IRI + 5-FU/LV compared with 5-FU/LV; about 1.3 months shorter for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Second-line biliary tract cancer after gemcitabine: liposomal irinotecan + 5-FU/LV vs 5-FU/LV. People in a different situation may not see the same effect.
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 participants enrolled.
Overall survival
nal-IRI + 5-FU/LV
6.9 mo
5-FU/LV
8.2 mo
| 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 |