Early Stage HCC, HCC
Conditions
Keywords
Hepatocellular carcinoma, Radiofrequency ablation (RFA), Radioembolization, Quirem Spheres, Selective internal radiation therapy
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 percutaneous radiofrequency ablation in combination with RFA with adjuvant segmental radioembolization.
Detailed description
RFA + adjuvant radioembolsation with Quirem Spheres
Interventions
DEVICEQuirem Medical Holmium-166 radioembolization microspheres
radioembolisation as adjuvant treatment to RFA
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Health Holland
Quirem Medical B.V.
Medtronic
Maag Lever Darm Stichting
Leiden University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-arm, interventional, dose escalation study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-finding | 1 year | Treatment area dose that will result in delivery of a radiation absorbed dose of ≥ 120Gy to the target area in at least 90% of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | 1 year | Toxicity of RFA with adjuvant segmental radioembolization as assessed by complications according to CTCAE v4.0 |
| Local tumor recurrence | 6 months and 12 months | Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI |
| Time to progression | 1 year | time until disease progresses |
| Progression-free survival | 1 year | Kaplan-Meier analysis of progression free survival |
| Quality of Life | Throughout the first year after treatment. | Quality of Life will be assessed by means of the EORTC QLQ HCC-18 questionnaire |
Countries
Netherlands
Outcome results
None listed