NCT03044587View on ClinicalTrials.gov

Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

January 24, 2018

Primary Completion Date

January 1, 2022

Study Completion Date

January 31, 2025

Conditions
Adenocarcinoma MetastaticBiliary Tract CancerAdenocarcinoma of the Biliary TractAdenocarinoma Locally AdvancedNon-Resectable Hepatocellular CarcinomaIntrahepatic Bile Duct CarcinomaExtrahepatic Bile Duct Carcinoma
Interventions
DRUG

Arm NaI-IRI + 5-FU + Leucovorin (Arm A)

Nal-IRI (80 mg/m2 as a 1.5 hour infusion), 5-FU (2400 mg/m2 as 46 hour infusion) and Leucovorin (400 mg/m2 as 0.5 hour infusion) Cycle q2w

DRUG

Arm Cisplatin + Gemcitabine (Arm B)

Cisplatin (25 mg/m2 as 1 hour infusion on D1, D8) and Gemcitabine (1000 mg/m2 as 0.5 hour infusion on D1, D8) Cycle q3w

Trial Locations (1)

89081

Universitätsklinikum Ulm, Ulm

All Listed Sponsors
collaborator

Servier

INDUSTRY

collaborator

Institut für Klinisch-Onkologische Forschung der Krankenhaus Nordwest GmbH

UNKNOWN

lead

AIO-Studien-gGmbH

OTHER

NCT03044587 - Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer | Biotech Hunter | Biotech Hunter