{"entity":{"id":"naliricc","kind":"trial","name":"NALIRICC (AIO)","aka":[],"tldr":"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.","status":"negative","asOf":"2026-09-07","links":[{"label":"Lancet Gastroenterol Hepatol 2024","url":"https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00119-5/fulltext"}],"tags":["failure","lesson:replication"],"related":[],"cancers":["cholangiocarcinoma","gallbladder","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["liposomal-irinotecan","fluorouracil","leucovorin"],"companies":["aio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-naliricc-lancet-gastroenterol-hepatol-2024"],"journals":[],"dependsOn":[],"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."],"nct":"NCT03043547","phase":"2","setting":"Second-line biliary tract cancer after gemcitabine: liposomal irinotecan + 5-FU/LV vs 5-FU/LV","sponsor":"AIO (Germany)","result":"OS 6.9 vs 8.2 months; not improved.","started":"2017-10-24","startedType":"actual","yearReported":2024,"enrolled":100,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","unit":"months","arms":[{"name":"nal-IRI + 5-FU/LV","value":6.9},{"name":"5-FU/LV","value":8.2}]}]},"route":"/trials/naliricc/","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/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"liposomal-irinotecan","kind":"drug","name":"Liposomal irinotecan","route":"/drugs/liposomal-irinotecan/"}],"company":[{"id":"aio","kind":"company","name":"AIO (Arbeitsgemeinschaft Internistische Onkologie)","route":"/companies/aio/"}],"paper":[{"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","route":"/key-papers/paper-nifty-liposomal-irinotecan-lancet-oncol-2021/"},{"id":"paper-naliricc-lancet-gastroenterol-hepatol-2024","kind":"paper","name":"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","route":"/key-papers/paper-naliricc-lancet-gastroenterol-hepatol-2024/"}],"trial":[{"id":"nifty","kind":"trial","name":"NIFTY","route":"/trials/nifty/"}],"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/"}]}}