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

NCT03043547 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-18

No results posted yet for this study

Summary

is an open label, randomized, multicenter phase II trial

Conditions

  • Cholangiocarcinoma Non-resectable
  • Cholangiocarcinoma Metastatic
  • Cholangiocarcinoma of the Gallbladder
  • Cholangiocarcinoma 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)

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Arndt Vogel, Prof. · Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2021-12-08
Completion
2022-03-08

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT03043547 on ClinicalTrials.gov