RecruitingNCT06873269

Holmium-166 Transarterial Radioembolization for the Treatment of Hepatocellular Carcinoma

Sponsor

Universitair Ziekenhuis Brussel

Enrollment

100 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

Locally Advanced Hepatocellular Carcinoma Liver Cirrhosis Non-metastatic Hepatocellular Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted radiation treatment called Holmium-166 transarterial radioembolization (TARE) — where tiny radioactive beads are delivered directly into the blood vessels feeding a liver tumor — for people with advanced liver cancer (hepatocellular carcinoma, HCC) that cannot be removed by surgery. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with locally advanced liver cancer (HCC) without spread to other parts of the body - Your cancer cannot be treated with surgery or radiofrequency ablation (a procedure that burns the tumor) - A specialist team has determined you are a good candidate for this radioactive bead treatment - You are in good health (ECOG performance status 0–2) with relatively preserved liver function (Child-Pugh A or B) **You may NOT be eligible if...** - You have previously received systemic therapy (chemotherapy or immunotherapy) or liver radiation for HCC - You have cancer that has spread outside the liver - You have another active cancer at the same time - You have serious blood vessel problems or a bleeding disorder that makes the procedure unsafe - You have serious uncontrolled infections or heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBaseline 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).

RADIATIONholmium-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

OTHERFollow-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