HCCHORA EST HCCNCT03437382
Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study
A study testing Quirem Medical Holmium-166 radioembolization microspheres in people with HCC and Early Stage HCC, run by Leiden University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC, Early Stage HCC
- What is being tested?
- Quirem Medical Holmium-166 radioembolization microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2018to 17 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Bilirubin < 2mg/dL
- ASAT < 5x upper limit of normal
- ALAT < 5x upper limit of normal
- Thrombocytes ≥ 50 X 10^9/L
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
Official title: 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.
Read the detailed description
RFA + adjuvant radioembolsation with Quirem Spheres
- Conditions
- HCC, Early Stage HCC
- Being tested
- Quirem Medical Holmium-166 radioembolization microspheres
- Keywords
- Hepatocellular carcinoma, Radiofrequency ablation (RFA), Radioembolization, Quirem Spheres, Selective internal radiation therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quirem Medical Holmium-166 radioembolization microspheresDevice
radioembolisation as adjuvant treatment to RFA
| Study group | Role | What they receive |
|---|---|---|
| RFA + radioembolization | Other | Quirem Medical Holmium-166 radioembolization microspheres Receives: Device: Quirem Medical Holmium-166 radioembolization microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
Toxicity
Toxicity of RFA with adjuvant segmental radioembolization as assessed by complications according to CTCAE v4.0
Measured: 1 year
Local tumor recurrence
Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI
Measured: 6 months and 12 months
Time to progression
time until disease progresses
Measured: 1 year
Progression-free survival
Kaplan-Meier analysis of progression free survival
Measured: 1 year
Quality of Life
Quality of Life will be assessed by means of the EORTC QLQ HCC-18 questionnaire
Measured: Throughout the first year after treatment.
Quality of Life
Quality of Life will be assessed by means of the C-30 questionnaire
Measured: Throughout the first year after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jul 2018
- Primary completion17 Mar 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm, interventional, dose escalation study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Health Holland, Quirem Medical B.V., Medtronic, Maag Lever Darm Stichting
- Responsible party
- Principal investigator, MCBurgmans, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437382
- Sponsor's protocol ID
- P17.161
- Other IDs
- ZonMW
- Acronym
- HORA EST HCC
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach S, van Delden OM, Dibbets-Schneider P, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular and Cholangiocarcinoma Group. Adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients: a dose-finding study (HORA EST HCC trial). Eur J Nucl Med Mol Imaging. 2024 Jun;51(7):2085-2097. doi: 10.1007/s00259-024-06630-z. Epub 2024 Feb 8.
PubMed 38329507Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach ASLP, van Delden OM, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular Cholangiocarcinoma Group. Study Protocol: Adjuvant Holmium-166 Radioembolization After Radiofrequency Ablation in Early-Stage Hepatocellular Carcinoma Patients-A Dose-Finding Study (HORA EST HCC Trial). Cardiovasc Intervent Radiol. 2022 Aug;45(8):1057-1063. doi: 10.1007/s00270-022-03162-7. Epub 2022 May 26.
PubMed 35618860
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOlmium Radioembolization as Adjuvant Treatment to Radiofrequency Ablation for Early STage Hepatocellular Carcinoma (HORA EST HCC)
- ClinicalTrials.gov ID
- NCT03437382
- Acronym / sponsor ID
- HORA EST HCC / P17.161
- Conditions
- HCC, Early Stage HCC
- Keywords
- Hepatocellular carcinoma, Radiofrequency ablation (RFA), Radioembolization, Quirem Spheres, Selective internal radiation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Health Holland, Quirem Medical B.V., Medtronic, Maag Lever Darm Stichting
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RFA + adjuvant radioembolsation with Quirem Spheres
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm, interventional, dose escalation study
| Arm | Type | Receives |
|---|---|---|
| RFA + radioembolization | Other | Device: Quirem Medical Holmium-166 radioembolization microspheresQuirem Medical Holmium-166 radioembolization microspheres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- Recurrent HCC
- Tumor location precluding percutaneous RFA
- Bilobar tumor involvement
- Vascular tumor invasion or extrahepatic metastasis
- Hemihepatectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quirem Medical Holmium-166 radioembolization microspheresradioembolisation as adjuvant treatment to RFA | Device | RFA + radioembolization |
Primary outcome
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.
6 secondary outcomes
Toxicity
Time frame: 1 year
Local tumor recurrence
Time frame: 6 months and 12 months
Time to progression
Time frame: 1 year
Progression-free survival
Time frame: 1 year
Quality of Life
Time frame: Throughout the first year after treatment.
Quality of Life
Time frame: Throughout the first year after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Derived from this study: PubMed 38329507Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach S, van Delden OM, Dibbets-Schneider P, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular and Cholangiocarcinoma Group. Adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients: a dose-finding study (HORA EST HCC trial). Eur J Nucl Med Mol Imaging. 2024 Jun;51(7):2085-2097. doi: 10.1007/s00259-024-06630-z. Epub 2024 Feb 8.
- Derived from this study: PubMed 35618860Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach ASLP, van Delden OM, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular Cholangiocarcinoma Group. Study Protocol: Adjuvant Holmium-166 Radioembolization After Radiofrequency Ablation in Early-Stage Hepatocellular Carcinoma Patients-A Dose-Finding Study (HORA EST HCC Trial). Cardiovasc Intervent Radiol. 2022 Aug;45(8):1057-1063. doi: 10.1007/s00270-022-03162-7. Epub 2022 May 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quirem Medical Holmium-166 radioembolization microspheres in people with HCC and Early Stage HCC, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-finding (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03437382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.