- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437382
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
Status
Completed
Conditions
Intervention / Treatment
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
Keywords
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.
Clinical Trials on HCC
-
University of PisaAzienda Ospedaliera Città della Salute e della Scienza di Torino; Fondazione... and other collaboratorsRecruiting
-
Seoul National University HospitalPhilips HealthcareCompleted
-
Huazhong University of Science and TechnologyUnknown
-
Taipei Medical University WanFang HospitalTerminated
-
Qianfoshan HospitalNot yet recruiting
-
Xuhua DuanRecruiting
-
Ain Shams UniversityCompleted
-
Shenyang Tenth People's HospitalBeijing Tsinghua Changgeng HospitalNot yet recruiting
-
Chen XiaopingNot yet recruiting
Clinical Trials on Quirem Medical Holmium-166 radioembolization microspheres
-
UMC UtrechtCompletedNeuroendocrine TumorsNetherlands
-
Terumo Europe N.V.CompletedHepatocellular Carcinoma | Metastatic CancerNetherlands, Germany, Switzerland, Belgium, Spain, Portugal, Italy
-
UMC UtrechtErasmus Medical Center; Dutch Cancer Society; Quirem Medical B.V.CompletedHepatocellular Carcinoma | Hepatocellular Carcinoma Non-resectableNetherlands
-
UMC UtrechtErasmus Medical Center; Terumo CorporationRecruitingHepatocellular Carcinoma Non-resectableNetherlands
-
Terumo Europe N.V.RecruitingHepatocellular CarcinomaGermany
-
UMC UtrechtCompletedLiver Tumors | Liver MetastasisNetherlands
-
UMC UtrechtTerminatedHead and Neck Neoplasms | RadioisotopesNetherlands
-
Radboud University Medical CenterTerumo Medical Corporation; Quirem Medical B.V.Recruiting
-
Erasme University HospitalTerumo Europe N.V.CompletedHepatocellular CarcinomaBelgium
-
UMC UtrechtCompletedLiver NeoplasmsNetherlands