A phase II, randomized, double-blind, placebo controlled trial of Sorafenib as adjuvant treatment for hepatocellular carcinoma after TACE-based treatments. - ONC-2009-002

Conditions: hepatocellular carcinoma
MedDRA version: 14.1Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-023411-33-IT

Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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