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Effectiveness and Safety Study of TACE Plus Oral Sorafenib for Unresectable HCC

NCT00576056 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-02-15

Study results available
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Summary

The purpose of this study is to determine if TACE plus Sorafenib will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Sorafenib

Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.

DRUG

TACE

TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Thomas C Gamblin, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00576056 on ClinicalTrials.gov