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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin or Carboplatin With Gemcitabine in Combination With Irinotecan-loaded Beads (LC or ONCOZENE) Versus Cisplatin or Carbopla

Brief 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.

Detailed Summary:
Sponsor: Robert C. Martin

Current Primary Outcome: Tumor response according to modified RECIST Criteria [ Time Frame: 10 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Hepatic Progression Free Survival [ Time Frame: Progression ]

Original Secondary Outcome: Hepatic Progression Free Survival

Information By: University of Louisville

Dates:
Date Received: July 17, 2012
Date Started: July 2012
Date Completion: July 2020
Last Updated: April 18, 2017
Last Verified: August 2016