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.
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
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
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
Cohort
Retrospective
Baseline assessment
Other interventiondemographic 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 radioembolization
RadiationCharacteristics 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 phase
Other interventionThe 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
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)
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)
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
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