Status:
COMPLETED
Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Health Holland
Conditions:
HCC
Early Stage HCC
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 percutaneo...
Detailed Description
RFA + adjuvant radioembolsation with Quirem Spheres
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03437382
Start Date
July 1 2018
End Date
March 17 2021
Last Update
March 18 2021
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA