Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin

NCT01648023 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-02-27

Study results available
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Summary

The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.

Conditions

  • Unresectable Intrahepatic Cholangiocarcinoma

Interventions

DEVICE

LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo

DRUG

Gem-Cis or Gem-Carbo

Sponsors & Collaborators

  • Robert C. Martin

    lead OTHER

Principal Investigators

  • Robert Martin, MD, PhD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2019-01-31
Completion
2019-09-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

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 NCT01648023 on ClinicalTrials.gov