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

niversitair Medisch Centrum Utrecht0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•- Written informed consent
•- Diagnosis HCC confirmed by typical appearance on imaging, i.e. hypervascular enhancing lesion in the arterial phase and contrast washout in the portal venous or delayed phase, or by cytohistological tissue sampling by biopsy in case of inconclusive imaging findings
•- 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

•- 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
•- 99mTc-MAA-scintigraphy shows limited MAA uptake (photopenic lesion)
•- Lung shunting fraction >20%
•- 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

niversitair Medisch Centrum Utrecht