NCT01272557

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: PD Dr. med. Matthias Dollinger · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2011-01-07
• Last updated: 2014-04-01

Locations

6 sites across 1 country: Germany