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

NCT00846131 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-09-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sorafenib

Randomized to Y-90 ± Sorafenib

DRUG

Yttrium-90 (Y-90)

Patients undergo radioembolization with Yttrium 90 microspheres by hepatic artery infusion

Sponsors & Collaborators

Principal Investigators

  • Laura Kulik, MD · Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

  • Riad Salem, MD · Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-07-31
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00846131 on ClinicalTrials.gov