{"entity":{"id":"nct07099794","kind":"trial","name":"A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen","aka":[],"tldr":"A phase 2 trial of fluorouracil, liposomal irinotecan and lenvatinib in gallbladder cancer and other biliary tract cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, not yet recruiting.","summary":"A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen is a phase 2, randomised interventional study registered as NCT07099794 by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with a registry enrolment figure of 90 participants, started 2025-08-01 and due to reach its primary completion in 2029-02-28. Interventions recorded: Liposomal irinotecan+5-FU/LV+Lenvatinib, NALIRI. Conditions listed: Biliary Tract Cancer (BTC). Gallbladder cancer is named in the registry entry: \"* Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07099794","url":"https://clinicaltrials.gov/study/NCT07099794"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors"],"targets":[],"drugs":["fluorouracil","liposomal-irinotecan","lenvatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07099794","phase":"2","setting":"Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","enrolled":90,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07099794/","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":"extrahepatic-cholangiocarcinoma","kind":"cancer","name":"Extrahepatic cholangiocarcinoma (perihilar and distal)","route":"/cancers/extrahepatic-cholangiocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"lenvatinib","kind":"drug","name":"Lenvatinib","route":"/drugs/lenvatinib/"},{"id":"liposomal-irinotecan","kind":"drug","name":"Liposomal irinotecan","route":"/drugs/liposomal-irinotecan/"}],"term":[{"id":"gallbladder-cancer-in-biliary-trials","kind":"term","name":"Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)","route":"/terms/gallbladder-cancer-in-biliary-trials/"}]}}