Y-90 Alone or With Sorafenib for Pre-Transplant Hepatocellular Carcinoma

Completed · Phase 1

Conditions studied: Hepatocellular Carcinoma

In brief

A research study to determine the safety, efficacy, and tolerability of Therasphere® (also known as Y-90, or Y-90 Therasphere) combined with or without sorafenib (Nexavar®), in patients with hepatocellular carcinoma (HCC, or liver cancer), awaiting liver transplantation.

Key facts

Study ID

NCT00846131

Run by

Northwestern University

People needed

24

Starts

2009-02-01

Expected to finish

2016-09-01

Last updated by the study team

2016-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult > 18 years olf of either gender
• Diagnosis of HCC confirmed by biopsy, CT, or MRI
• Able to carry out activities of daily living, awake >50% of waking hours
• Meets eligibility for liver transplantation
• No prior treatment for HCC
• Ability to understand and sign the informed consent
• Child-bearing women and any men agree to use two forms of birth control (one of which should be a barrier method) during the course of therapy and for 8 weeks afterward.

You may not qualify if…

• Less than or = 18 years old
• Ineligible for transplant due to comorbid disease
• Renal Failure requiring dialysis of any kind
• Severe Cardiac disease
• History of a stroke
• Evidence of metastatic disease- or tumors that have spread outside the liver
• Known human immunodeficiency virus (HIV) infection
• Uncontrolled blood pressure (systolic > 160) despite medication(s)
• Major surgery within 4 weeks prior to the screening visit
• Active clinically serious infection
• Serious non-healing wound, ulcer, or bone fracture.
• History of gastrointestinal bleeding (GIB) within 6 weeks prior to the screening visit
• Prior transplant of any kind
• Must be able to swallow oral pills, tablets or capsules of any size
• Use of St. John's Wort or rifampin (rifampicin).
• Currently being treated with Interferon and/or Ribavirin therapy due to the thrombocytopenias, lymphopenias and anemias observed with use of these two medications.
• Known or suspected allergy to sorafenib or any agent given in the course of this trial.
• Any malabsorption problem
• Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test 7 days prior to beginning therapy.
• No potential living donor transplant (LDT-donor identified and worked up by the time of randomization into this study. If a living donor is later identified- the subject will be allowed to continue in the study. Sorafenib will be stopped at a minimum of 7 days prior to transplant surgery.
• Active alcohol use, drug use, or a psychiatric disease that would, in the opinion of the PI or a subinvestigator (sub-I), prevent the subject from complying with the study protocol and/or endanger the subject during their participation in the study
• Inability of the potential subject to read, understand and sign the informed consent document

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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