Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study (HORA EST HCC)

March 17, 2021 updated by: MCBurgmans, Leiden University Medical Center

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

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.

Study Overview

Detailed Description

RFA + adjuvant radioembolsation with Quirem Spheres

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333ZA
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RFA + radioembolization
Quirem Medical Holmium-166 radioembolization microspheres
radioembolisation as adjuvant treatment to RFA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

March 17, 2021

Study Completion (Actual)

March 17, 2021

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • P17.161
  • ZonMW (Other Grant/Funding Number: PTO 2017 - 40-41200-98-9286)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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