Holmium-166 Transarterial Radioembolization for the Treatment of Hepatocellular Carcinoma
Universitair Ziekenhuis Brussel
100 participants
Feb 1, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- 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
Exclusion Criteria7
- 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
Interventions
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).
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
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06873269