hepatocellular carcinoma liver cancer
Conditions
Interventions
The intervention consists of either treatment with TACE-DEB, the standard of
care, or 90Y-RE.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - Inadequate bone marrow function (hemoglobulin 45 µmol/l (or 2.6 mg/dl), albumin 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 6 seconds over control)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: time to progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: overall survival, tumor response, toxicities/adverse events, treatment related effect on total liver function, quality of life and treatment-related costs. | — |
Countries
Netherlands
Outcome results
None listed