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

ISTITUTO CLINICO HUMANITAS0 个研究点开始时间: 2011年12月28日最近更新: 2013年6月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

ISTITUTO CLINICO HUMANITAS