Sorafenib in the first line treatment of advanced hepatocellular carcinoma with ChildPugh liver function class B. Multicentre phase 3 randomized trial - BOOST

Conditions: advanced hepatocellular carcinoma with ChildPugh liver function class B
MedDRA version: 9.1Level: LLTClassification code 10024720

Registration Number: EUCTR2009-013870-42-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

? Patients with diagnosis of HCC according to the AASLD- EASL criteria (10) ? 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 class B ? ECOG performance status ? 2 ? Adequate renal (creatinine ? 1.5 x ULN), and haematological function (platelet count ? 60 x 10^9/L, hemoglobin ? 9 g/dl) ? Life expectancy of at least 2 months ? Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Prior exposure to sorafenib ? Performance Status (ECOG) ?3 ? Concomitant diseases that contraindicates the use of sorafenib ? Gastro-intestinal bleeding in the previous 30 days ? Serious active infections (> grade 2 CTCAE version 3.0) ? Pregnant or lactating women ? Not cooperative patients ? Inability of patients to access to the hospital ? Grade 3-4 encephalopathy that makes the patient not able to follow study procedures (Table 2) ? Refusal of informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to compare two doses of sorafenib (800 and 400 mg/day) with best supportive care in terms of survival in HCC patients with impaired liver function (Child B).;Secondary Objective: to compare the three treatment arms in terms of toxicity and quality of life.;Primary end point(s): OVERALL SURVIVA

Secondary Outcome Measures