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Completed

NCT Number: NCT03437382

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

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.

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Key information

Conditions

HCC Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Early Stage HCC Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

About this study

RFA + adjuvant radioembolsation with Quirem Spheres

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quirem Medical Holmium-166 radioembolization microspheres

Device

radioembolisation as adjuvant treatment to RFA

Primary outcomes

  1. 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.

Secondary outcomes

  1. Toxicity

    Time frame: 1 year

    Toxicity of RFA with adjuvant segmental radioembolization as assessed by complications according to CTCAE v4.0

  2. Local tumor recurrence

    Time frame: 6 months and 12 months

    Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI

  3. Time to progression

    Time frame: 1 year

    time until disease progresses

  4. Progression-free survival

    Time frame: 1 year

    Kaplan-Meier analysis of progression free survival

  5. 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

  6. Quality of Life

    Time frame: Throughout the first year after treatment.

    Quality of Life will be assessed by means of the C-30 questionnaire

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Health Holland
  • Maag Lever Darm Stichting
  • Medtronic
  • Quirem Medical B.V.
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: HORA EST HCC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 19, 2018
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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