hepatocellular carcinoma MedDRA version: 14.1 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration number: 200-
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histological or cytological confirmation of HCC or meet the AASLD criteria for diagnosis of HCC Radiological CR (as per mRECIST,Lencioni R. & Llovet M. 2010) after TACE +/- RFA or PEI procedures. Assessment of radiological CR after TACE that employed Lipiodol, will be done by MRI only Are the trial subjects under 18? no Number of subjects for this age range: 0 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients that are candidates for radical (potentially curative) treatments including patients waiting for liver transplant 2. Presence of macroscopic vascular invasion (including segmental portal obstruction) or extrahepatic spread 3. Ascites refractory to diuretics 4. Subject undergoing renal dialysis 5. Active clinically serious infection (> grade 2 NCI-CTC version 4.0) 6. Prior systemic therapy for HCC with TKIs or agents acting on VEGFR 7. Investigational therapy within 4 weeks of trial entry 8. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry 9. Thrombotic or embolic events (cerebrovascular accident including transient ischemic attacks, deep vein thrombosis or pulmonary embolism) within 6 months prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of sorafenib versus placebo in the adjuvant treatment of patients with hepatocellular carcinoma (HCC) after treatments with TACE.;Secondary Objective: overall survival the disease-free survival the number of patients without disease at 2 years the percentage of patients who develop extrahepatic spread or macroscopic vascular invasion;Primary end point(s): To evaluate the efficacy and safety of sorafenib versus placebo in the adjuvant treatment of patients with hepatocellular carcinoma (HCC) after treatments with TACE. | — |
Countries
Italy
Outcome results
None listed