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