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

HCC Clinical Trial

— HORA EST HCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437382
• Other study ID #: P17.161
• Secondary ID: ZonMW
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: March 17, 2021

Study information

• Verified date: March 2021
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

RFA + adjuvant radioembolsation with Quirem Spheres

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 17, 2021
• Est. primary completion date: March 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early Stage HCC
• HCC

Intervention

Device:
• Quirem Medical Holmium-166 radioembolization microspheres
radioembolisation as adjuvant treatment to RFA

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (6)

Lead Sponsor	Collaborator
Leiden University Medical Center	Health Holland, Maag Lever Darm Stichting, Medtronic, Quirem Medical B.V., ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

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