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Holmium-166 Transarterial Radioembolization for the Treatment of Hepatocellular Carcinoma

NCT06873269 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-03-12

No results posted yet for this study

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. 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.

Conditions

  • Locally Advanced Hepatocellular Carcinoma
  • Liver Cirrhosis
  • Non-metastatic Hepatocellular Carcinoma

Interventions

OTHER

Baseline assessment

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).

RADIATION

holmium-166 radioembolization

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

OTHER

Follow-up phase

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

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-02-01
Completion
2026-02-01

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873269 on ClinicalTrials.gov