Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study

Study Overview
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Brief Summary
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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
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RFA + adjuvant radioembolsation with Quirem Spheres

Official Title
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HOlmium Radioembolization as Adjuvant Treatment to Radiofrequency Ablation for Early STage Hepatocellular Carcinoma (HORA EST HCC)

Conditions
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HCC, Early Stage HCC

Intervention / Treatment
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* Device: Quirem Medical Holmium-166 radioembolization microspheres


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single-arm, interventional, dose escalation study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RFA + radioembolization<br>Quirem Medical Holmium-166 radioembolization microspheres | Device: Quirem Medical Holmium-166 radioembolization microspheres<br>* radioembolisation as adjuvant treatment to RFA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-finding | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | Toxicity of RFA with adjuvant segmental radioembolization as assessed by complications according to CTCAE v4.0 | 1 year | 
| Local tumor recurrence | Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI | 6 months and 12 months | 
| Time to progression | time until disease progresses | 1 year | 
| Progression-free survival | Kaplan-Meier analysis of progression free survival | 1 year | 
| Quality of Life | Quality of Life will be assessed by means of the EORTC QLQ HCC-18 questionnaire | Throughout the first year after treatment. | 
| Quality of Life | Quality of Life will be assessed by means of the C-30 questionnaire | Throughout the first year after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Radiofrequency ablation (RFA), Radioembolization, Quirem Spheres, Selective internal radiation therapy