Locally Advanced Hepatocellular CarcinomaTARE for HCCNCT06873269
Holmium-166 Transarterial Radioembolization for the Treatment of Hepatocellular Carcinoma
An observational study of Locally Advanced Hepatocellular Carcinoma and Liver Cirrhosis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This study aims to evaluate the effectiveness and safety of Holmium-166 (Ho-166) transarterial radioembolization (TARE) for treating patients with locally advanced hepatocellular carcinoma (HCC), a common type of liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Hepatocellular Carcinoma, Liver Cirrhosis, Non-metastatic Hepatocellular Carcinoma
- What is being tested?
- Baseline assessment, holmium-166 radioembolization and Follow-up phase
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: 1. Patients must have been diagnosed with HCC based on: o Mass larger than 1 cm with pathognomonic HCC imaging hallmarks (arterial phase hyperenhancement (APHE) and washout on portal venous and/or delayed phases) on multiphasic contrast-enhanced CT or MRI in a cirrhotic liver. AND/OR o Lesions in the liver with histopathological diagnosis of HCC on biopsy. 2. Based on BCLC staging, the disease must be locally advanced without extra-hepatic disease and after assessment by a multidisciplinary tumor board, the patient was considered suitable for protocol treatment with Holmium-166 TARE
Who may be able to join
- aged 18 year or older
- diagnosed with locally advanced HCC without extra-hepatic metastases
- HCC must not be amendable to treatment by surgical resection or percutaneous radiofrequency ablation
- after assessment by the investigator and multidisciplinary tumor board, the patient is considered suitable for protocol treatment with Holmium-166 TARE
- ECOG performance status 0-2
- child-Pugh A-B
- tumor response evaluable with mRECIST criteria during follow-up
Who cannot join
- prior treatment with any of the following treatment modalities for HCC: systemic therapy, hepatic radiation therapy
- currently enrolled in clinical studies where patient receive investigational therapeutic drug
- metastatic disease
- concurrent malignancy
- active contra-indications to angiography or selective catherization (i.e. severe vascular disease or bleeding diathesis)
- uncontrolled and/or severe comorbidities (active infection, heart failure,...) with limited estimated life expectancy
- history of or know allergic reactions to used compounds
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels
UZ Brussel, 024776001, virgini.vanbuggenhout@uzbrussel.be
About this study
This study aims to evaluate the effectiveness and safety of Holmium-166 (Ho-166) transarterial radioembolization (TARE) for treating patients with locally advanced hepatocellular carcinoma (HCC), a common type of liver cancer. HCC is often linked to conditions like liver cirrhosis and viral hepatitis, with a poor prognosis for advanced stages. TARE involves delivering radioactive particles directly to liver tumors, sparing healthy tissue and providing targeted radiation.
This study will include patients diagnosed with HCC who have received Holmium-166 TARE treatment between January 2010 and December 2024. Researchers will look at patient and tumor characteristics, side effects, how well the treatment works, and survival outcomes. The goal is to determine whether Holmium-166 TARE is a safe and effective treatment option for people with locally advanced HCC.
The findings will help doctors better understand how this therapy can be used to treat liver cancer and whether it can improve survival rates for patients with this challenging disease.
Read the detailed description
This study investigates the use of Holmium-166 (Ho-166) transarterial radioembolization (TARE) as a treatment for patients with locally advanced hepatocellular carcinoma (HCC), a primary liver cancer. The research focuses on evaluating both the safety and effectiveness of this therapeutic approach in patients who have been diagnosed with HCC and treated with Ho-166 TARE between January 2010 and December 2024.
HCC is a highly aggressive cancer that commonly arises in individuals with liver cirrhosis, often due to underlying chronic viral hepatitis or metabolic dysfunction-associated fatty liver disease (MAFLD). As the disease progresses, treatment options become limited, particularly in cases where the cancer has reached advanced stages with symptoms, vascular invasion, or extrahepatic spread. Holmium-166 TARE is an interventional procedure that involves delivering microspheres containing the radioactive isotope Holmium-166 directly to the tumor site via the hepatic artery. This targeted radiation therapy is designed to maximize tumor destruction while minimizing damage to surrounding healthy liver tissue.
The study will retrospectively analyze the medical records of patients who received Ho-166 TARE as part of their treatment plan. This includes examining factors such as patient demographics, tumor characteristics, treatment-related side effects or toxicity, radiologic response to the therapy, progression-free survival (PFS), and overall survival (OS). The primary aim is to assess whether Ho-166 TARE provides a significant benefit in terms of tumor response, survival outcomes, and safety when compared to other treatment modalities.
Pre-treatment planning for Holmium-166 TARE involves a detailed assessment of the liver's blood supply through angiography and the use of cone-beam CT and SPECT/CT scans to guide precise delivery of the radioactive microspheres. The dosage is tailored to each patient, aiming to deliver over 150 Gy to the tumor while keeping the healthy liver dose below critical thresholds.
By focusing on a diverse patient population with locally advanced HCC, this study seeks to provide important data that could help refine treatment strategies for liver cancer. The results may support the broader use of Ho-166 TARE in clinical practice, especially for patients who are not eligible for curative treatments like surgery or liver transplantation.
- Conditions
- Locally Advanced Hepatocellular Carcinoma, Liver Cirrhosis, Non-metastatic Hepatocellular Carcinoma
- Being tested
- Baseline assessment, holmium-166 radioembolization, Follow-up phase
- Keywords
- holmium-166, transarterial radioembolization
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline assessmentOther
demographic information (age, gender, ethnicity), relevant medical, surgical and oncological history (number and types of previous treatments), clinical assessment (including Child Pugh score, BCLC stage), functional assessment (ECOG performance status), baseline laboratory findings (liver and kidney function, AFP tumor marker,..), date of diagnosis, baseline imaging characteristics (number, size, location of lesions, portal vein thrombosis, TNM stage) and if available histopathological diagnosis (grade of differentiation, microvascular invasion).
holmium-166 radioembolizationRadiation
Characteristics of treatment: treatment date, predicted target dose in Gy, predicted non-target dose in Gy, target volume in mL, whole liver volume in mL, administered activity in GBq, tumor absorbed dose, normal liver-absorbed dose Aim of TARE: palliative or curative/downstaging
Follow-up phaseOther
The following data on the performed monitoring after the procedure with clinical assessment, imaging modalities and blood samples as determined by the center, will be collected retrospectively:
- Response: tumor response on imaging, tumor marker (AFP levels) at 3, 6 and 12 months after Ho166-TARE, and thereafter every 6 months until last follow-up or death, date of progression, time to progression after treatment
- Toxicity and safety: side effects, adverse events, hepatic function parameters, presence of ascites or hepatic encephalopathy
- Survival: date of last follow-up or death
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of Holmium-166 TARE in patients with locally advanced HCC
To assess the efficacy of Holmium-166 TARE in patients with locally advanced HCC in terms of tumor response rate (RR)
Measured: through study completion, on average 60 months
efficacy of Holmium-166 TARE in patients with locally advanced HCC
To assess the efficacy of Holmium-166 TARE in patients with locally advanced HCC in terms of overall survival (OS)
Measured: through study completion, on average 60 months
Secondary outcomes (1)
progression-free survival (PFS), time to disease progression and toxicity and safety during follow-up
progression-free survival (PFS), time to disease progression and toxicity and safety during follow-up
Measured: through study completion, on average 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873269
- Sponsor's protocol ID
- TARE for HCC
- Acronym
- TARE for HCC
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium-166 Transarterial Radioembolization for the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06873269
- Acronym / sponsor ID
- TARE for HCC / TARE for HCC
- Conditions
- Locally Advanced Hepatocellular Carcinoma, Liver Cirrhosis, Non-metastatic Hepatocellular Carcinoma
- Keywords
- holmium-166, transarterial radioembolization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 12 Mar 2025 (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.
This study aims to evaluate the effectiveness and safety of Holmium-166 (Ho-166) transarterial radioembolization (TARE) for treating patients with locally advanced hepatocellular carcinoma (HCC), a common type of liver cancer. HCC is often linked to conditions like liver cirrhosis and viral hepatitis, with a poor prognosis for advanced stages. TARE involves delivering radioactive particles directly to liver tumors, sparing healthy tissue and providing targeted radiation.
This study will include patients diagnosed with HCC who have received Holmium-166 TARE treatment between January 2010 and December 2024. Researchers will look at patient and tumor characteristics, side effects, how well the treatment works, and survival outcomes. The goal is to determine whether Holmium-166 TARE is a safe and effective treatment option for people with locally advanced HCC.
The findings will help doctors better understand how this therapy can be used to treat liver cancer and whether it can improve survival rates for patients with this challenging disease.
Detailed description
This study investigates the use of Holmium-166 (Ho-166) transarterial radioembolization (TARE) as a treatment for patients with locally advanced hepatocellular carcinoma (HCC), a primary liver cancer. The research focuses on evaluating both the safety and effectiveness of this therapeutic approach in patients who have been diagnosed with HCC and treated with Ho-166 TARE between January 2010 and December 2024.
HCC is a highly aggressive cancer that commonly arises in individuals with liver cirrhosis, often due to underlying chronic viral hepatitis or metabolic dysfunction-associated fatty liver disease (MAFLD). As the disease progresses, treatment options become limited, particularly in cases where the cancer has reached advanced stages with symptoms, vascular invasion, or extrahepatic spread. Holmium-166 TARE is an interventional procedure that involves delivering microspheres containing the radioactive isotope Holmium-166 directly to the tumor site via the hepatic artery. This targeted radiation therapy is designed to maximize tumor destruction while minimizing damage to surrounding healthy liver tissue.
The study will retrospectively analyze the medical records of patients who received Ho-166 TARE as part of their treatment plan. This includes examining factors such as patient demographics, tumor characteristics, treatment-related side effects or toxicity, radiologic response to the therapy, progression-free survival (PFS), and overall survival (OS). The primary aim is to assess whether Ho-166 TARE provides a significant benefit in terms of tumor response, survival outcomes, and safety when compared to other treatment modalities.
Pre-treatment planning for Holmium-166 TARE involves a detailed assessment of the liver's blood supply through angiography and the use of cone-beam CT and SPECT/CT scans to guide precise delivery of the radioactive microspheres. The dosage is tailored to each patient, aiming to deliver over 150 Gy to the tumor while keeping the healthy liver dose below critical thresholds.
By focusing on a diverse patient population with locally advanced HCC, this study seeks to provide important data that could help refine treatment strategies for liver cancer. The results may support the broader use of Ho-166 TARE in clinical practice, especially for patients who are not eligible for curative treatments like surgery or liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients must have been diagnosed with HCC based on: o Mass larger than 1 cm with pathognomonic HCC imaging hallmarks (arterial phase hyperenhancement (APHE) and washout on portal venous and/or delayed phases) on multiphasic contrast-enhanced CT or MRI in a cirrhotic liver. AND/OR o Lesions in the liver with histopathological diagnosis of HCC on biopsy. 2. Based on BCLC staging, the disease must be locally advanced without extra-hepatic disease and after assessment by a multidisciplinary tumor board, the patient was considered suitable for protocol treatment with Holmium-166 TARE
Key inclusion criteria (7 listed)
- aged 18 year or older
- diagnosed with locally advanced HCC without extra-hepatic metastases
- HCC must not be amendable to treatment by surgical resection or percutaneous radiofrequency ablation
- after assessment by the investigator and multidisciplinary tumor board, the patient is considered suitable for protocol treatment with Holmium-166 TARE
- ECOG performance status 0-2
Key exclusion criteria (7 listed)
- prior treatment with any of the following treatment modalities for HCC: systemic therapy, hepatic radiation therapy
- currently enrolled in clinical studies where patient receive investigational therapeutic drug
- metastatic disease
- concurrent malignancy
- active contra-indications to angiography or selective catherization (i.e. severe vascular disease or bleeding diathesis)
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 |
|---|---|---|
| Baseline assessmentdemographic information (age, gender, ethnicity), relevant medical, surgical and oncological history (number and types of previous treatments), clinical assessment (including Child Pugh score, BCLC stage), functional assessment (ECOG performance status), baseline laboratory findings (liver and kidney function, AFP tumor marker,..), date of diagnosis, baseline imaging characteristics (number, size, location of lesions, portal vein thrombosis, TNM stage) and if available histopathological diagnosis (grade of differentiation, microvascular invasion). | Other | – |
| holmium-166 radioembolizationCharacteristics of treatment: treatment date, predicted target dose in Gy, predicted non-target dose in Gy, target volume in mL, whole liver volume in mL, administered activity in GBq, tumor absorbed dose, normal liver-absorbed dose Aim of TARE: palliative or curative/downstaging | Radiation | – |
| Follow-up phaseThe following data on the performed monitoring after the procedure with clinical assessment, imaging modalities and blood samples as determined by the center, will be collected retrospectively: * Response: tumor response on imaging, tumor marker (AFP levels) at 3, 6 and 12 months after Ho166-TARE, and thereafter every 6 months until last follow-up or death, date of progression, time to progression after treatment * Toxicity and safety: side effects, adverse events, hepatic function parameters, presence of ascites or hepatic encephalopathy * Survival: date of last follow-up or death | Other | – |
Primary outcome
efficacy of Holmium-166 TARE in patients with locally advanced HCC
Time frame: through study completion, on average 60 months
To assess the efficacy of Holmium-166 TARE in patients with locally advanced HCC in terms of tumor response rate (RR)
efficacy of Holmium-166 TARE in patients with locally advanced HCC
Time frame: through study completion, on average 60 months
To assess the efficacy of Holmium-166 TARE in patients with locally advanced HCC in terms of overall survival (OS)
1 secondary outcome
progression-free survival (PFS), time to disease progression and toxicity and safety during follow-up
Time frame: through study completion, on average 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Hepatocellular Carcinoma and Liver Cirrhosis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena Degroote (02476 3308, Helena.Degroote@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of Holmium-166 TARE in patients with locally advanced HCC (time frame: through study completion, on average 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.