Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma.

NCT05451862 | Terminated

• 1 other identifier: T142E3
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

166Ho-TARE is a promising modality for the treatment of HCC, given the unique characteristics of holmium, allowing careful patient selection and personalized dosimetry treatment planning. Further clinical evidence is needed to evaluate the safety and efficacy of 166Ho-TARE in the treatment of HCC patients with limited tumor burden, well preserved liver function and performance status and ineligible for liver transplantation and/or liver resection. This study will also provide further evidence on the dose-response relationship of 166Ho-TARE in (early) HCC.

Conditions

Hepatocellular Carcinoma

Keywords

early stage HCC; TARE; SIRT; radioembolization; Holmium-166

Outcome Measures

Primary Outcomes (1)

• confirmed Objective Response Rate (ORR) by localized mRECIST

  ORR is defined as the proportion of patients achieving either complete or partial tumor response during the study, as assessed by blinded central image review according to localized mRECIST

  5 years

Secondary Outcomes (17)

• Best ORR based on localized mRECIST

  5 years

• Best and confirmed ORR based on mRECIST

  5 years

• Duration of Response (DoR) ≥ 6 months based on localized mRECIST and mRECIST

  5 years

• Time to Progression (TTP)

  5 years

• Progression-Free Survival (PFS)

  5 years

Study Arms (1)

166Ho-TARE treatment

OTHER

Patients with unresectable HCC with a single nodule ≤ 8 cm or up to three nodules with a diameter of ≤ 5 cm (each). Those patients who fulfil the initial selection criteria will undergo a work-up procedure for further screening of 166Ho-TARE eligibility. If a patient is deemed eligible for 166Ho-TARE, the patient will be included in the study.

Device: Holmium-166 treatment; Device: Holmium-166 work-up

Interventions

Holmium-166 treatment DEVICE

Implantation into hepatic tumors by delivery via the hepatic artery for the treatment of unresectable HCC liver tumors.

Also known as: QuiremSpheresTM Holmium-166 Microspheres

166Ho-TARE treatment

Holmium-166 work-up DEVICE

Evaluation of lung-shunt, extrahepatic deposition and intrahepatic distribution of intra-arterially injected microspheres for patients that are eligible for TARE treatment.

Also known as: QuiremScoutTM Holmium-166 Microspheres

166Ho-TARE treatment

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Multidisciplinary tumor board decision for locoregional treatment
• Freely given, written informed consent
• Patients with unresectable HCC with a single nodule ≤ 8 cm or up to three nodules with a diameter of ≤ 5 cm (each) eligible for selective radioembolization (including position changes of infusion catheters)
• Non-cirrhotic patients or Child-Pugh A cirrhosis
• ECOG performance status 0-1
• Using an acceptable method of contraception throughout the study until survival follow up (for subjects of childbearing potential)
• Adequate hematological, renal and liver function.
• Adequate hematological function defined as:
• Hemoglobin ≥ 6 mmol/L (9.7 g/dL)
• WBC ≥ 3.0 x 10E9/L
• Absolute neutrophil count ≥ 1.5 x 10E9/L
• Platelet count ≥ 50,000/mm3
• Adequate renal function defined as:
• Serum urea and serum creatinine \< 1.5 times upper limit of normal (ULN)

You may not qualify if:

• Diffuse and/or infiltrative HCC (defined as HCC consisting of multiple tiny liver nodules spreading throughout the entire liver or entire lobe, without a dominant nodule)
• Hypoperfused HCC (defined as a lack of tumor blush (i.e. reduced or no uptake of contrast fluid) observed on the intra-procedural CT)
• No full, selective arterial coverage on intra-procedural CT
• Life expectancy \< 6 months
• Child-Pugh score ≥7 points
• Prior liver transplantation
• Prior locoregional or systemic anti-cancer therapy for HCC and previous malignancies
• Macrovascular invasion (defined as macrovascular invasion of the hepatic and/or portal vein main branches)
• Extrahepatic metastases
• Clinically significant ascites
• Hepatic encephalopathy
• Untreated active hepatitis B and/or C
• Work-up imaging showing:
• Lung shunt \> 30 Gy is simulated on 166Ho-scout imaging; or
• Uncorrectable extrahepatic deposition of simulated 166Ho-scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted; or

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (2)

Universitätsklinikum Augsburg

Augsburg, Germany

Location

LMU Klinikum

Munich, Germany

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jens Ricke, Prof. Dr. med

  Ludwig-Maximilian-University Munich (LMU)

  PRINCIPAL INVESTIGATOR

• Wolfgang Weber, Prof. Dr. med

  Munich Technische Universität (TUM)

  PRINCIPAL INVESTIGATOR

• Thomas Kröncke, Prof. Dr. med

  Universitätsklinikum Augsburg

  PRINCIPAL INVESTIGATOR

• Ralph Kickuth, Prof. Dr. med

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

• Karin Menhart, Dr.

  Universitätsklinikum Regensburg

  PRINCIPAL INVESTIGATOR

• Peter Dietrich, PD. Dr. med.

  Uniklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 11, 2022
• Study Start: August 21, 2023
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)