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

Completed

• Conditions: hepatocellular carcinoma; liver cancer; 10019815

• Registration Number: NL-OMON38056
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

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

- 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: time to progression.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: overall survival, tumor response, toxicities/adverse<br /><br>events, treatment related effect on total liver function, quality of life and<br /><br>treatment-related costs.</p><br>