Transarterial RAdioembolization versus ChemoEmbolization for the treatment of HCC: A multicenter randomized controlled trial - TRACE trial

niversity Medical Center Utrecht0 个研究点目标入组 140 人开始时间: 2011年9月26日最近更新: 2013年12月9日

试验速览

暂无简介。

•- Diagnosis HCC
•- Intermediate stage HCC as defined by the BCLC criteria, i.e. >3 lesions >3cm in size, or 1 lesion >5cm in size (BCLC stage B )
•- absence of extrahepatic disease
•- Age > 18 years
•- Child-Pugh A-B7
•- ECOG performance status (PST) 0-1
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•- Inadequate bone marrow function (hemoglobulin <6.0 mmol/l, absolute neutrophil count < 1.5 x 109/l, platelet count <60 x 109/l)
•- Inadequate liver function (bilirubin >45 µmol/l (or 2.6 mg/dl), albumin <28 g/l, AST/ALT >5x upper limit of normal (ULN))
•- Inadequate renal function (creatinine >1.5x ULN)
•- Compromised biliary system
•- Hypersensivity to doxorubicin
•- Pregnancy or breast feeding
•- >50% of liver involvement
•- main portal vein (right, left or common trunk) thrombosis
•- Patients who are declared incompetent or suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis
•- Previous local treatment of study target lesion(s)
•- Allergy for i.v. contrast used (Visipaque®)
•- Life expectancy <3 months or otherwise impossible follow-up
•- Patients in whom hepatic artery catheterization is contraindicated; such as patients with vascular abnormalities or bleeding diathesis (indicated by a PT >6 seconds over control)

发起方