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

• Sponsor: Leiden University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03437382
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development (Other), Health Holland (Other), Quirem Medical B.V. (Other), Medtronic (Industry), Maag Lever Darm Stichting (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 32.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HCC; Early Stage HCC	Device: Quirem Medical Holmium-166 radioembolization microspheres	N/A

Detailed Description

RFA + adjuvant radioembolsation with Quirem Spheres

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single-arm, interventional, dose escalation studysingle-arm, interventional, dose escalation study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HOlmium Radioembolization as Adjuvant Treatment to Radiofrequency Ablation for Early STage Hepatocellular Carcinoma (HORA EST HCC)
• Actual Study Start Date: Jul 1, 2018
• Actual Primary Completion Date: Mar 17, 2021
• Actual Study Completion Date: Mar 17, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Toxicity [1 year]

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

2. Local tumor recurrence [6 months and 12 months]

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

3. Time to progression [1 year]

   time until disease progresses

4. Progression-free survival [1 year]

   Kaplan-Meier analysis of progression free survival

5. Quality of Life [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 [Throughout the first year after treatment.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leiden University Medical Center	Leiden	Zuid-Holland	Netherlands	2333ZA

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MCBurgmans, Principle Investigator, Leiden University Medical Center
• ClinicalTrials.gov Identifier: NCT03437382
• Other Study ID Numbers: P17.161; ZonMW
• First Posted: Feb 19, 2018
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by MCBurgmans, Principle Investigator, Leiden University Medical Center: Hepatocellular carcinoma; Radiofrequency ablation (RFA); Radioembolization; Quirem Spheres; Selective internal radiation therapy

Study Results

No Results Posted as of Mar 18, 2021