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Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Advanced Hepatocellular Carcinoma (HCC)

NCT00703365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-08-29

No results posted yet for this study

Summary

This study is to evaluate the efficacy and safety of Sorafenib in combination with Gemcitabine in patients with advanced/unresectable HCC.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Sorafenib and Gemcitabine

Sorafenib 400 mg po bid daily and Gemcitabine IV 1,000 mg/m2 on day 1,8, 15 of a 28-day cycle (up to 6 cycles), then followed by Sorafenib 400 mg po bid daily maintenance until disease progression.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Chulalongkorn University

    collaborator OTHER

  • Bumrungrad International Hospital

    collaborator OTHER

  • Mahidol University

    lead OTHER

Principal Investigators

  • Vichien Srimuninnimit, Assist.Prof. · Siriraj Hospital, Bangkok, Thailand

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-01-31
Completion
2011-08-31

Countries

  • Thailand

Study Locations

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Entities

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 NCT00703365 on ClinicalTrials.gov