Clinical Trial: 90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

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

Official Title: A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma

Brief Summary: The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90 Y TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma (ICC).

Detailed Summary:
Sponsor: Medical University of South Carolina

Current Primary Outcome: Presence or absence of a dose limiting toxicity (DLT) of 90Y TARE in combination with gemcitabine and cisplatin. [ Time Frame: 6 weeks of study treatment ]

A continual reassessment method (CRM) design will be used to identify the maximum-tolerated dose (MTD)


Original Primary Outcome: Presence or absence of a DLT of 90Y TARE in combination with gemcitabine and cisplatin. [ Time Frame: 6 weeks of study treatment ]

A continual reassessment method (CRM) design will be used to identify the maximum-tolerated dose (MTD)


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medical University of South Carolina

Dates:
Date Received: July 29, 2015
Date Started: July 2015
Date Completion: July 2019
Last Updated: May 4, 2017
Last Verified: March 2017