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
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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