# 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

Source: https://onco.cc/trials/nct07099794/  
OnCo record `nct07099794` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Tags: ctgov-ingest; gallbladder-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT07099794: https://clinicaltrials.gov/study/NCT07099794

## Connected records

- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Lenvatinib](https://onco.cc/drugs/lenvatinib/), [Liposomal irinotecan](https://onco.cc/drugs/liposomal-irinotecan/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)

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