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

Not Applicable

Completed

• Conditions: HCC; Early Stage HCC
• Interventions: Device: Quirem Medical Holmium-166 radioembolization microspheres

• Registration Number: NCT03437382
• Lead Sponsor: Leiden University Medical Center

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

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-19
• Study Start: 2018-07-01
• Status Verified: 2021-03
• Primary Completion: 2021-03-17
• Study Completion: 2021-03-17
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RFA + radioembolization	Quirem Medical Holmium-166 radioembolization microspheres	Quirem Medical Holmium-166 radioembolization microspheres

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 C-30 questionnaire
Time to progression	1 year	time until disease progresses

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands