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

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Patients with diagnosis of hepatic cell carcinoma (HCC) according to the AASLD- EASL criteria

• Age >18 years

• Advanced stage of disease defined as HCC not eligible for locoregional treatments (ab initio or following progression after such treatments)

• Liver function classified as Child-Pugh class B

• ECOG performance status < or = 2

• Life expectancy of at least 2 months

• Adequate contraception for fertile male and female patients

• Signed informed consent

Exclusion Criteria:

• Prior exposure to sorafenib or antiangiogenesis drugs

• Concomitant diseases that contraindicate the use of sorafenib

• Gastro-intestinal bleeding in the previous 30 days

• Altered renal function(creatinine > 1.5 x ULN), or haematological function (platelet count < 60 x 10^9/L, hemoglobin < 9 g/dl)

• Serious active infections (> grade 2 CTCAE version 3.0)

• Congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia

• Patients who are unable or unwilling to participate in the study

• Pregnant or lactating females

• Hepatic encephalopathy of any grade