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Sorafenib Plus Doxorubicin Versus Sorafenib Alone for the Treatment of Advanced Hepatocellular Carcinoma: a Randomized Phase II Trial

NCT01272557 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2014-04-01

No results posted yet for this study

Summary

This study is a prospective, randomized, open-label, multicenter phase IIB trial in order to determine time to progression of the combination therapy sorafenib plus doxorubicin against standard-of-care sorafenib in advanced HCC not amenable to non-systemic treatment.

Conditions

  • Liver Carcinoma

Interventions

DRUG

Doxorubicin

Doxorubicin 60 mg/m2 i.v. on day 1 every 21 days Sorafenib 400 mg bid (oral) from day 3-19 every 21 days. Maximum accumulative dose of doxorubicin: 360 mg/m2 (thereafter sorafenib monotherapy continuously until progression or unacceptable toxicity).

DRUG

Sorafenib

Sorafenib 400 mg bid (oral) continuously

Sponsors & Collaborators

  • PD Dr. med. Matthias Dollinger

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs

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 NCT01272557 on ClinicalTrials.gov