Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study (HORA EST HCC)

Leiden University Medical Center (LUMC)

Status

Completed

Conditions

Early Stage HCC

HCC

Treatments

Device: Quirem Medical Holmium-166 radioembolization microspheres

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03437382

P17.161

ZonMW (Other Grant/Funding Number)

Details and patient eligibility

About

In this multi-center, dose-finding study, patients with early stage hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer (BCLC) staging system will be included to receive percutaneous radiofrequency ablation in combination with RFA with adjuvant segmental radioembolization.

Full description

RFA + adjuvant radioembolsation with Quirem Spheres

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent
Age > 18 years
Single HCC lesion with diameter of ≥ 2-5cm or up to three lesions with each lesion measuring no more than 3cm (confined to one lobe)
HCC diagnosis is based on histology or non-invasive imaging criteria according to EORTC-EASL guidelines
Child Pugh A or B ≤7
ECOG performance status ≤ 2
Bilirubin < 2mg/dL
ASAT < 5x upper limit of normal
ALAT < 5x upper limit of normal
Thrombocytes ≥ 50 X 10^9/L

Exclusion criteria

Recurrent HCC
Tumor location precluding percutaneous RFA
Bilobar tumor involvement
Vascular tumor invasion or extrahepatic metastasis
Hemihepatectomy
Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections)
Uncorrectable coagulopathy
Large arterio-portovenous shunt
Previous radiotherapy to the liver
Surgical hepatico-enterostomy
Hepatic resection with placement of surgical clips that may cause artefacts on MRI
Incompetent/ mentally disabled
Pregnancy, inadequate anticonception
Calculated lung dose >30Gy
Creatinine clearance < 50 ml/min