Clinical trial NCT03437382: Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study
Official title: HOlmium Radioembolization as Adjuvant Treatment to Radiofrequency Ablation for Early STage Hepatocellular Carcinoma (HORA EST HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HCC
Early Stage HCC
Keywords: Hepatocellular carcinoma
Radiofrequency ablation (RFA)
Radioembolization
Quirem Spheres
Selective internal radiation therapy
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Health Holland
name: Quirem Medical B.V.
name: Medtronic
name: Maag Lever Darm Stichting
First posted: 2018-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm, interventional, dose escalation study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: RFA + adjuvant radioembolsation with Quirem Spheres

Eligibility criteria: 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

Primary outcomes:
measure: Dose-finding
timeFrame: 1 year
Secondary outcomes:
measure: Toxicity
timeFrame: 1 year
measure: Local tumor recurrence
timeFrame: 6 months and 12 months
measure: Time to progression
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
measure: Quality of Life
timeFrame: Throughout the first year after treatment.
measure: Quality of Life
timeFrame: Throughout the first year after treatment.
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
References:
citation: Hendriks 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.