NCT01405573

Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma

Sorafenib in the First Line Treatment of Advanced Hepatocellular Carcinoma With Child-Pugh Liver Function Class B: Multicentre Phase 3 Randomized Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best supportive care with best supportive care alone in terms of survival in patients with hepatocellular carcinoma (HCC) with impaired liver function (Child B).

Detailed description

Hepatocellular carcinoma (HCC) is the third cause of death for cancer in the world with an increasing incidence. No systemic therapy has proven effective in patients with advanced HCC until 2007, when results of the SHARP trial were presented. In this trial, the orally active multi-kinase inhibitor sorafenib (800 mg/day) significantly prolonged survival compared with placebo in patients with advanced HCC and good liver function (Child A). The same authors concluded that the effect of the drug in the population of patients with more impaired liver function should be further studied.

Conditions

• Advanced Adult Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	Best Supportive Care	Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.
DRUG	sorafenib	400 mg twice a day

Timeline

• Start date: 2011-07-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2011-07-29
• Last updated: 2017-03-28

Locations

25 sites across 1 country: Italy