Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 92
Summary
- Conditions
- Adenocarcinoma Metastatic
- Adenocarcinoma of the Biliary Tract
- Adenocarinoma Locally Advanced
- Biliary Tract Cancer
- Extrahepatic Bile Duct Carcinoma
- Intrahepatic Bile Duct Carcinoma
- Non-Resectable Hepatocellular Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary objective is to determine whether a combination of 5-FU and nal-IRI prolongs progression-free survival in patients with locally advanced or metastatic adenocarcinoma of the biliary tract
The primary objective is to determine whether a combination of 5-FU and nal-IRI prolongs progression-free survival in patients with locally advanced or metastatic adenocarcinoma of the biliary tract
Tracking Information
- NCT #
- NCT03044587
- Collaborators
- Servier
- Institut für Klinisch-Onkologische Forschung der Krankenhaus Nordwest GmbH
- Investigators
- Principal Investigator: Thomas J. Ettrich, Dr. Klinik für Innere Medizin I, Universitätsklinikum Ulm
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