Nal-IRI(Nanoliposomal Irinotecan) Plus 5-FU/LV in Metastatic Biliary Tract Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

178

Participants

Timeline

Start Date

September 4, 2018

Primary Completion Date

September 30, 2020

Study Completion Date

December 31, 2021

Conditions
Metastatic Biliary Tract Cancer
Interventions
DRUG

Onivyde

The recommended dose and regimen of Onivyde is 70 mg/m2 intravenously over 90 minutes, followed by dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks.

DRUG

5-FU/LV

The recommended dose and regimen of dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks

Trial Locations (1)

05505

Asan Medical Center, Seoul

All Listed Sponsors
collaborator

Ulsan University Hospital

OTHER

collaborator

Chungnam National University Hospital

OTHER

collaborator

Kyungpook National University Chilgok Hospital

OTHER

collaborator

Inje University

OTHER

lead

Changhoon Yoo

OTHER

NCT03524508 - Nal-IRI(Nanoliposomal Irinotecan) Plus 5-FU/LV in Metastatic Biliary Tract Cancer | Biotech Hunter | Biotech Hunter