Holmium-166 Transarterial Radioembolization for the Treatment of Hepatocellular Carcinoma

NCT06873269 | Recruiting

• 1 other identifier: TARE for HCC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

holmium-166; transarterial radioembolization

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  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

  through study completion, on average 60 months

Interventions

Baseline assessment OTHER

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 radioembolization RADIATION

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 phase OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Helena Degroote

CONTACT

02476 3308; Helena.Degroote@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 12, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

BE (1)