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Randomized phase II trial of fluorouracil and folinic acid with or without liposomal irinotecan (ONIVYDE) for metastatic biliary tract cancer after gemcitabine plus cisplatin
KCT0003022Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2018
- Countries
- 1
- Sponsor
- Servier
- Modality
- Small Molecules, Liposomes → Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
- Drugs
- irinotecan liposome
- Conditions
- biliary cancer
01
Overview
Phase 2, randomised trial of irinotecan liposome in biliary cancer (2 arms), sponsored by Servier. Started Sep 2018; status: completed.
02
Design
2 arms- Study design
- Randomized
ONIVYDE + fluorouracil + folinic acid
Patients receive liposomal irinotecan (ONIVYDE) in combination with fluorouracil and folinic acid as subsequent-line chemotherapy.
Fluorouracil + folinic acid
Patients receive fluorouracil and folinic acid without ONIVYDE as the active control regimen.
03
Who it enrols
Adults with metastatic biliary tract cancer that has radiographically or clinically progressed following prior gemcitabine plus cisplatin therapy.
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