NCT03043547View on ClinicalTrials.gov

Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 24, 2017

Primary Completion Date

December 8, 2021

Study Completion Date

March 8, 2022

Conditions
Cholangiocarcinoma Non-resectableCholangiocarcinoma MetastaticCholangiocarcinoma of the GallbladderCholangiocarcinoma Advanced
Interventions
DRUG

nal-IRI

nal-IRI \[Irinotecan liposome\] (80 mg/m2 as a 1.5 hour infusion)

DRUG

5-FU

5-FU \[5-Fluorouracil\] (2400 mg/m2 as 46 hour infusion)

DRUG

leucovorin

leucovorin (400 mg/m2 as 0.5 hour infusion)

Trial Locations (1)

30625

Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hanover

All Listed Sponsors
collaborator

Servier

INDUSTRY

lead

AIO-Studien-gGmbH

OTHER

NCT03043547 - Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies | Biotech Hunter | Biotech Hunter