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Nal-IRI(Nanoliposomal Irinotecan) Plus 5-FU/LV in Metastatic Biliary Tract Cancer

NCT03524508 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2022-08-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of combination of fluorouracil/folinic acid and liposomal irinotecan(Onivyde) compared with fluoruracil/folinic acid in patients with metastatic biliary tract cancer which progressed on 1st line gemcitabine/cisplatin.

Conditions

  • Metastatic Biliary Tract Cancer

Interventions

DRUG

Onivyde

The recommended dose and regimen of Onivyde is 70 mg/m2 intravenously over 90 minutes, followed by dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks.

DRUG

5-FU/LV

The recommended dose and regimen of dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks

Sponsors & Collaborators

  • Ulsan University Hospital

    collaborator OTHER

  • Chungnam National University Hospital

    collaborator OTHER

  • Kyungpook National University Chilgok Hospital

    collaborator OTHER

  • Inje University

    collaborator OTHER

  • Changhoon Yoo

    lead OTHER

Principal Investigators

  • Changhoon Yoo · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2020-09-30
Completion
2021-12-31

Countries

  • South Korea

Study Locations

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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 NCT03524508 on ClinicalTrials.gov