{"entity":{"id":"paper-nifty-liposomal-irinotecan-lancet-oncol-2021","kind":"paper","name":"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","aka":[],"tldr":"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.","asOf":"2026-09-24","links":[{"label":"Lancet Oncol 2021","url":"https://doi.org/10.1016/S1470-2045(21)00486-1"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34656226/"},{"label":"ClinicalTrials.gov NCT03524508","url":"https://clinicaltrials.gov/study/NCT03524508"}],"tags":["gallbladder-evidence"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["irinotecan","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":["pfs"],"trials":["nifty","naliricc"],"people":["ghassan-abou-alfa"],"bottlenecks":[],"keyPapers":[],"journals":["lancet-oncology"],"dependsOn":[],"notes":[],"journal":"The Lancet Oncology","year":2021,"doi":"10.1016/S1470-2045(21)00486-1","pmid":"34656226","authors":"Yoo C, Kim KP, Jeong JH, et al.","paperType":"rct","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."],"whatItMeans":"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)."],"changedPractice":false,"participants":174},"route":"/key-papers/paper-nifty-liposomal-irinotecan-lancet-oncol-2021/","neighbours":{"cancer":[{"id":"biliary-tract-cancer","kind":"cancer","name":"Biliary tract cancer (all types)","route":"/cancers/biliary-tract-cancer/"},{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"irinotecan","kind":"drug","name":"Irinotecan (and liposomal irinotecan)","route":"/drugs/irinotecan/"}],"term":[{"id":"pfs","kind":"term","name":"Progression-free survival (PFS)","route":"/terms/pfs/"}],"trial":[{"id":"naliricc","kind":"trial","name":"NALIRICC (AIO)","route":"/trials/naliricc/"},{"id":"nifty","kind":"trial","name":"NIFTY","route":"/trials/nifty/"}],"person":[{"id":"ghassan-abou-alfa","kind":"person","name":"Ghassan K. Abou-Alfa","route":"/people/ghassan-abou-alfa/"}],"journal":[{"id":"lancet-oncology","kind":"journal","name":"The Lancet Oncology","route":"/journals/lancet-oncology/"}],"roadmap":[{"id":"gallbladder-cancer-roadmap","kind":"roadmap","name":"Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials","route":"/roadmaps/gallbladder-cancer-roadmap/"}]}}