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A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

NCT00855218 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2017-08-18

Study results available
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Summary

This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. \[twice daily\], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead

DRUG

Placebo

4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-07-31
Completion
2013-02-28

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Singapore
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

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 NCT00855218 on ClinicalTrials.gov