# 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

Source: https://onco.cc/key-papers/paper-nifty-liposomal-irinotecan-lancet-oncol-2021/  
OnCo record `paper-nifty-liposomal-irinotecan-lancet-oncol-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In a Korean trial, adding liposomal irinotecan to fluorouracil held second-line bile duct and gallbladder cancer still for about seven months rather than six weeks, at the cost of more low blood counts.

## Summary

NIFTY randomised 174 patients at five South Korean academic centres between September 2018 and February 2020 to liposomal irinotecan 70 mg/m2 with fluorouracil and leucovorin, or fluorouracil and leucovorin alone, every two weeks. Median progression-free survival by blinded independent central review was 7.1 months (95 percent CI 3.6 to 8.8) against 1.4 months (1.2 to 1.5); hazard ratio 0.56 (0.39 to 0.81), p=0.0019. Grade 3 to 4 neutropenia occurred in 24 versus 1 percent and serious adverse events in 42 versus 24 percent, with no treatment-related deaths.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Tags: gallbladder-evidence
- Journal: The Lancet Oncology
- Year: 2021
- DOI: 10.1016/S1470-2045(21)00486-1
- Authors: Yoo C, Kim KP, Jeong JH, et al.
- Findings: Median progression-free survival 7.1 vs 1.4 months; hazard ratio 0.56 (95 percent CI 0.39 to 0.81), p=0.0019.; Grade 3 to 4 neutropenia 24 vs 1 percent; serious adverse events 42 vs 24 percent.
- What it means: 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.
- Caveats: Phase 2b with a progression-free survival endpoint, not survival.; Not reproduced by NALIRICC (2024).

## Sources

- Lancet Oncol 2021: https://doi.org/10.1016/S1470-2045(21)00486-1
- PubMed: https://pubmed.ncbi.nlm.nih.gov/34656226/
- ClinicalTrials.gov NCT03524508: https://clinicaltrials.gov/study/NCT03524508

## 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/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Irinotecan (and liposomal irinotecan)](https://onco.cc/drugs/irinotecan/)
- terms: [Progression-free survival (PFS)](https://onco.cc/terms/pfs/)
- trials: [NALIRICC (AIO)](https://onco.cc/trials/naliricc/), [NIFTY](https://onco.cc/trials/nifty/)
- people: [Ghassan K. Abou-Alfa](https://onco.cc/people/ghassan-abou-alfa/)
- journals: [The Lancet Oncology](https://onco.cc/journals/lancet-oncology/)
- 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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