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

NCT03044587 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2025-10-01

No results posted yet for this study

Summary

AIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II trial

Conditions

  • Adenocarcinoma Metastatic
  • Biliary Tract Cancer
  • Adenocarcinoma of the Biliary Tract
  • Adenocarinoma Locally Advanced
  • Non-Resectable Hepatocellular Carcinoma
  • Intrahepatic Bile Duct Carcinoma
  • Extrahepatic 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

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY

  • Institut für Klinisch-Onkologische Forschung der Krankenhaus Nordwest GmbH

    collaborator UNKNOWN

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Thomas J. Ettrich, Dr. · Klinik für Innere Medizin I, Universitätsklinikum Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2022-01-01
Completion
2025-01-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044587 on ClinicalTrials.gov