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Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

NCT00692770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1114

Last updated 2018-08-08

Study results available
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Summary

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Nexavar (Sorafenib, BAY43-9006)

Sorafenib 400 mg twice daily (BID)

DRUG

Placebo

Placebo 2 tablets twice daily (BID)

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
2008-08-15
Primary Completion
2013-11-29
Completion
2014-11-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • France
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Mexico
  • New Zealand
  • Portugal
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

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 NCT00692770 on ClinicalTrials.gov