NCT03437382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2.7 years

First QC Date

January 31, 2018

Last Update Submit

March 17, 2021

Conditions

HCCEarly Stage HCC

Keywords

Hepatocellular carcinomaRadiofrequency ablation (RFA)RadioembolizationQuirem SpheresSelective internal radiation therapy

Outcome Measures

Primary Outcomes (1)

  • Dose-finding

    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.

    1 year

Secondary Outcomes (6)

  • Toxicity

    1 year

  • Local tumor recurrence

    6 months and 12 months

  • Time to progression

    1 year

  • Progression-free survival

    1 year

  • Quality of Life

    Throughout the first year after treatment.

  • +1 more secondary outcomes

Study Arms (1)

RFA + radioembolization

OTHER

Quirem Medical Holmium-166 radioembolization microspheres

Device: Quirem Medical Holmium-166 radioembolization microspheres

Interventions

Quirem Medical Holmium-166 radioembolization microspheresDEVICE

radioembolisation as adjuvant treatment to RFA

RFA + radioembolization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

Related Publications (2)

  • Hendriks 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: 38329507DERIVED

  • 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.

    PMID: 35618860DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single-arm, interventional, dose escalation study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 19, 2018

Study Start

July 1, 2018

Primary Completion

March 17, 2021

Study Completion

March 17, 2021

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

NL(1)