Last updated on June 2019

SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma


Brief description of study

The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone.

Detailed Study Description

This clinical study is a prospective, multicenter, randomized, controlled study evaluating SIR-Spheres Y-90 resin microspheres followed by cisplatin-gemcitabine (CIS-GEM) chemotherapy vs. CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma.

Randomized patients will be followed until death, withdrawal of consent, or until end of study.

Clinical Study Identifier: NCT02807181

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St. Joseph Hospital

Orange, CA United States
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Northside Hospital

Atlanta, GA United States
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Kansas University

Kansas City, KS United States
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University of Pennsylvania

Philadelphia, PA United States
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Providence Health Care

Spokane, WA United States
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Box Hill Hospital

Box Hill, Australia
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UZ Leuven

Leuven, Belgium
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CHU Dijon

Dijon, France
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CHU Montpellier

Montpellier, France
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Southampton General Hospital

Southampton, United Kingdom
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Recruitment Status: Open


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