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Hepatocellular CarcinomaHOMIE-166NCT05451862

Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma.

A study testing Holmium-166 treatment and Holmium-166 work-up in people with Hepatocellular Carcinoma, run by Terumo Europe N.V. at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

166Ho-TARE is a promising modality for the treatment of HCC, given the unique characteristics of holmium, allowing careful patient selection and personalized dosimetry treatment planning. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Holmium-166 treatment and Holmium-166 work-up
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesGermany
Study dates
21 Aug 2023to 27 May 2025
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

  • Age ≥ 18 years
  • Multidisciplinary tumor board decision for locoregional treatment
  • Freely given, written informed consent
  • Patients with unresectable HCC with a single nodule ≤ 8 cm or up to three nodules with a diameter of ≤ 5 cm (each) eligible for selective radioembolization (including position changes of infusion catheters)
  • Non-cirrhotic patients or Child-Pugh A cirrhosis
  • ECOG performance status 0-1
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  • Using an acceptable method of contraception throughout the study until survival follow up (for subjects of childbearing potential)
  • Adequate hematological, renal and liver function.
  • Adequate hematological function defined as:
  • Hemoglobin ≥ 6 mmol/L (9.7 g/dL)
  • WBC ≥ 3.0 x 10E9/L
  • Absolute neutrophil count ≥ 1.5 x 10E9/L
  • Platelet count ≥ 50,000/mm3
  • Adequate renal function defined as:
  • Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 45 ml/min
  • Adequate liver function defined as:
  • Total bilirubin ≤ 35µmol/L (2.05 mg/dL)
  • Albumin ≥ 30 g/L
  • AST and ALT ≤ 5X ULN

Who cannot join

  • Diffuse and/or infiltrative HCC (defined as HCC consisting of multiple tiny liver nodules spreading throughout the entire liver or entire lobe, without a dominant nodule)
  • Hypoperfused HCC (defined as a lack of tumor blush (i.e. reduced or no uptake of contrast fluid) observed on the intra-procedural CT)
  • No full, selective arterial coverage on intra-procedural CT
  • Life expectancy < 6 months
  • Child-Pugh score ≥7 points
  • Prior liver transplantation
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  • Prior locoregional or systemic anti-cancer therapy for HCC and previous malignancies
  • Macrovascular invasion (defined as macrovascular invasion of the hepatic and/or portal vein main branches)
  • Extrahepatic metastases
  • Clinically significant ascites
  • Hepatic encephalopathy
  • Untreated active hepatitis B and/or C
  • Work-up imaging showing:
  • Lung shunt > 30 Gy is simulated on 166Ho-scout imaging; or
  • Uncorrectable extrahepatic deposition of simulated 166Ho-scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted; or
  • Anticipated ineffective tumor targeting (< 150 Gy mean tumor simulated absorbed dose) of 166Ho-scout for each lesion; or
  • Entire tumor burden not within the perfused liver volume (possible extrahepatic collateral supply of the tumor); or
  • Perfused liver volume > 50% of whole liver tissue
  • Pregnant or breast-feeding
  • Current or history of cancer other than HCC, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
  • In the Investigator's opinion there is a reason that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  • Concurrently enrolled in another study, unless it is an observational non-interventional study

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Universitätsklinikum Augsburg

    Augsburg

  • LMU Klinikum

    Munich

Other trials in Germany

About this study

Official title: Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma; a Prospective, Single-arm, Open Label, Multicenter Phase II Study: HOMIE-166.

166Ho-TARE is a promising modality for the treatment of HCC, given the unique characteristics of holmium, allowing careful patient selection and personalized dosimetry treatment planning. Further clinical evidence is needed to evaluate the safety and efficacy of 166Ho-TARE in the treatment of HCC patients with limited tumor burden, well preserved liver function and performance status and ineligible for liver transplantation and/or liver resection. This study will also provide further evidence on the dose-response relationship of 166Ho-TARE in (early) HCC.

Read the detailed description

This is a prospective, single-arm, open-label, multicenter study with 166Ho-TARE in unresectable HCC patients with limited tumor burden and well-preserved liver function and performance status, ineligible for liver transplantation and/or liver resection. Eligibility for liver transplantation and liver resection is determined by the multidisciplinary tumor board. However, patients eligible for liver transplantation can still be included in the setting of bridge to transplant.

The study proposes to use 166Ho-TARE, including both therapeutic 166Ho-microspheres (QuiremSpheres™ Holmium-166 Microspheres) and scout 166Ho-microspheres (QuiremScout™ Holmium-166 Microspheres). All patients providing informed consent and meeting the selection criteria will be further screened using a scout dose of 166Ho-microspheres to evaluate 166Ho-TARE eligibility. Patients not eligible for selective 166Ho-TARE are considered screen failures and will not be considered as enrolled.

The primary endpoint will be assessed by blinded, independent central review, organized by an imaging core laboratory.

Being tested
Holmium-166 treatment, Holmium-166 work-up
Keywords
early stage HCC, TARE, SIRT, radioembolization, Holmium-166
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Holmium-166 treatmentDevice

    Also called QuiremSpheresTM Holmium-166 Microspheres

    Implantation into hepatic tumors by delivery via the hepatic artery for the treatment of unresectable HCC liver tumors.

  • Holmium-166 work-upDevice

    Also called QuiremScoutTM Holmium-166 Microspheres

    Evaluation of lung-shunt, extrahepatic deposition and intrahepatic distribution of intra-arterially injected microspheres for patients that are eligible for TARE treatment.

Study groups in NCT05451862
Study groupRoleWhat they receive
166Ho-TARE treatmentOtherPatients with unresectable HCC with a single nodule ≤ 8 cm or up to three nodules with a diameter of ≤ 5 cm (each). Those patients who fulfil the initial selection criteria will undergo a work-up procedure for further screening of 166Ho-TARE eligibility. If a patient is deemed eligible for 166Ho-TARE, the patient will be included in the study.
Receives: Device: Holmium-166 treatment; Device: Holmium-166 work-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. confirmed Objective Response Rate (ORR) by localized mRECIST

    ORR is defined as the proportion of patients achieving either complete or partial tumor response during the study, as assessed by blinded central image review according to localized mRECIST

    Measured: 5 years

Secondary outcomes (17)

  1. Best ORR based on localized mRECIST

    The number and percent of patients with a confirmed response

    Measured: 5 years

  2. Best and confirmed ORR based on mRECIST

    The number and percent of patients with a confirmed response

    Measured: 5 years

  3. Duration of Response (DoR) ≥ 6 months based on localized mRECIST and mRECIST

    The number and percent of patients with a DoR ≥ 6 months. DoR is measured from time of initial response until radiological progression. Radiological progression is determined by blinded central image review according to localized mRECIST and mRECIST.

    Measured: 5 years

  4. Time to Progression (TTP)

    TTP defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to progression as per mRECIST

    Measured: 5 years

  5. Progression-Free Survival (PFS)

    PFS defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to the date of radiological progression or death from any cause. Radiological progression is determined by blinded central image review according to mRECIST

    Measured: 5 years

  6. hepatic Progression-Free Survival (hPFS)

    hPFS defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to the date of radiological progression in the liver or death from any cause. Radiological progression is determined by blinded central image review according to mRECIST

    Measured: 5 years

  7. Liver transplantation rate

    The number and percent of patients receiving a liver transplant

    Measured: 5 years

  8. Liver resection rate

    The number and percent of patients undergoing a liver resection

    Measured: 5 years

  9. Overall survival (OS)

    The median overall survival time

    Measured: 5 years

  10. Safety and toxicity by evaluating the number of adverse events and the number of patients with each event

    Adverse events classified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. (including clinical and laboratory toxicity)

    Measured: 5 years

  11. Liver function during follow-up ALBI score

    ALBI score

    Measured: 5 years

  12. Liver function during follow-up using MELD score

    MELD score

    Measured: 5 years

  13. Liver function during follow-up using Child Pugh score

    Child Pugh score

    Measured: 5 years

  14. Assessment of dosimetry and biodistribution based on quantitative assessment of imaging scans

    Correlation between scout and treatment for extrahepatic dose deposition, including lung shunt and digestive shunting of QuiremSpheresTM Holmium-166 Microspheres.

    Measured: 5 years

  15. Assessment of dosimetry and biodistribution based on quantitative assessment of imaging scans

    Correlation between treatment-based absorbed dose (into the tumor and healthy liver) and clinical outcomes in terms of toxicity and efficacy (i.e. radiological response).

    Measured: 5 years

  16. Assessment of dosimetry and biodistribution based on quantitative assessment of imaging scans

    Correlation between scout-based simulated absorbed dose (into the tumor and healthy liver) and the treatment based absorbed dose (into the tumor and healthy liver).

    Measured: 5 years

  17. Quality of Life using EQ-5D-5L questionnaire

    Patient reported outcome using EQ-5D-5L questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start21 Aug 2023
  3. Primary completion27 May 2025
  4. Study completion27 May 2025

Why it stopped: The HOMIE-166 clinical investigation was prematurely terminated due to sponsor's decision to permanently stop production of QuiremSpheres™ and QuiremScouts™.

Resources

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
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451862
Sponsor's protocol ID
T142E3
Acronym
HOMIE-166
Status last verified
Aug 2025
First submitted
30 Jun 2022
Last updated
26 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Holmium-166 treatment and Holmium-166 work-up in people with Hepatocellular Carcinoma, run by Terumo Europe N.V. at 2 sites in Germany.

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 20 inclusion and 22 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: stopped early, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 was stopped early (reason given: The HOMIE-166 clinical investigation was prematurely terminated due to sponsor's decision to permanently stop production of QuiremSpheres™ and QuiremScouts™.). Results are not available in the source record.

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?

confirmed Objective Response Rate (ORR) by localized mRECIST (time frame: 5 years). 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 NCT05451862.

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 26 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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