Clinical trial · Interventional
Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study
HOlmium Radioembolization as Adjuvant Treatment to Radiofrequency Ablation for Early STage Hepatocellular Carcinoma (HORA EST HCC)
NCT03437382CI-TRIAL-00050741HORA EST HCCcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this multi-center, dose-finding study, patients with early stage hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer (BCLC) staging system will be included to receive percutaneous radiofrequency ablation in combination with RFA with adjuvant segmental radioembolization.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage HCC | — | UNRESOLVED | — |
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quirem Medical Holmium-166 radioembolization microspheres | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- RFA + radioembolization
- description
- Quirem Medical Holmium-166 radioembolization microspheres
- interventionNames
- Device: Quirem Medical Holmium-166 radioembolization microspheres
Primary outcomes (1)
- measure
- Dose-finding
- timeFrame
- 1 year
- description
- Treatment area dose that will result in delivery of a radiation absorbed dose of ≥ 120Gy to the target area in at least 90% of patients.
Secondary outcomes (6)
- measure
- Toxicity
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * Age \> 18 years * Single HCC lesion with diameter of ≥ 2-5cm or up to three lesions with each lesion measuring no more than 3cm (confined to one lobe) * HCC diagnosis is based on histology or non-invasive imaging criteria according to EORTC-EASL guidelines * Child Pugh A or B ≤7 * ECOG performance status ≤ 2 * Bilirubin \< 2mg/dL * ASAT \< 5x upper limit of normal * ALAT \< 5x upper limit of normal * Thrombocytes ≥ 50 X 10\^9/L Exclusion Criteria: * Recurrent HCC * Tumor location precluding percutaneous RFA * Bilobar tumor involvement * Vascular tumor invasion or extrahepatic metastasis * Hemihepatectomy * Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections) * Uncorrectable coagulopathy * Large arterio-portovenous shunt * Previous radiotherapy to the liver * Surgical hepatico-enterostomy * Hepatic resection with placement of surgical clips that may cause artefacts on MRI * Incompetent/ mentally disabled * Pregnancy, inadequate anticonception * Calculated lung dose \>30Gy * Creatinine clearance \< 50 ml/min
References
Publications (2)
- DERIVEDHendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach S, van Delden OM, Dibbets-Schneider P, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular and Cholangiocarcinoma Group. Adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients: a dose-finding study (HORA EST HCC trial). Eur J Nucl Med Mol Imaging. 2024 Jun;51(7):2085-2097. doi: 10.1007/s00259-024-06630-z. Epub 2024 Feb 8. PMID 38329507
- DERIVEDHendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach ASLP, van Delden OM, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular Cholangiocarcinoma Group. Study Protocol: Adjuvant Holmium-166 Radioembolization After Radiofrequency Ablation in Early-Stage Hepatocellular Carcinoma Patients-A Dose-Finding Study (HORA EST HCC Trial). Cardiovasc Intervent Radiol. 2022 Aug;45(8):1057-1063. doi: 10.1007/s00270-022-03162-7. Epub 2022 May 26. PMID 35618860