- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05451862
Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma. (HOMIE-166)
Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma; a Prospective, Single-arm, Open Label, Multicenter Phase II Study: HOMIE-166.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, single-arm, open-label, multicenter study with 166Ho-TARE in unresectable HCC patients with limited tumor burden and well-preserved liver function and performance status, ineligible for liver transplantation and/or liver resection. Eligibility for liver transplantation and liver resection is determined by the multidisciplinary tumor board. However, patients eligible for liver transplantation can still be included in the setting of bridge to transplant.
The study proposes to use 166Ho-TARE, including both therapeutic 166Ho-microspheres (QuiremSpheres™ Holmium-166 Microspheres) and scout 166Ho-microspheres (QuiremScout™ Holmium-166 Microspheres). All patients providing informed consent and meeting the selection criteria will be further screened using a scout dose of 166Ho-microspheres to evaluate 166Ho-TARE eligibility. Patients not eligible for selective 166Ho-TARE are considered screen failures and will not be considered as enrolled.
The primary endpoint will be assessed by blinded, independent central review, organized by an imaging core laboratory.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Florence Chow
- Phone Number: +32(0)16 38 12 11
- Email: florence.chow@terumo-europe.com
Study Contact Backup
- Name: Rijk De Jong
- Phone Number: +32(0)16 38 12 11
- Email: rijk.dejong@terumo-europe.com
Study Locations
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Munich, Germany
- Recruiting
- LMU Klinikum
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Contact:
- Jens Ricke, M.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
- Creatinine clearance ≥ 45 ml/min
Adequate liver function defined as:
- Total bilirubin ≤ 35µmol/L (2.05 mg/dL)
- Albumin ≥ 30 g/L
- AST and ALT ≤ 5X ULN
Exclusion Criteria:
- 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
- Anticipated ineffective tumor targeting (< 150 Gy mean tumor simulated absorbed dose) of 166Ho-scout for each lesion; or
- Entire tumor burden not within the perfused liver volume (possible extrahepatic collateral supply of the tumor); or
- Perfused liver volume > 50% of whole liver tissue
- Pregnant or breast-feeding
- Current or history of cancer other than HCC, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
- In the Investigator's opinion there is a reason that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- Concurrently enrolled in another study, unless it is an observational non-interventional study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 166Ho-TARE treatment
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.
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Implantation into hepatic tumors by delivery via the hepatic artery for the treatment of unresectable HCC liver tumors.
Other Names:
Evaluation of lung-shunt, extrahepatic deposition and intrahepatic distribution of intra-arterially injected microspheres for patients that are eligible for TARE treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
confirmed Objective Response Rate (ORR) by localized mRECIST
Time Frame: 5 years
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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
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best ORR based on localized mRECIST
Time Frame: 5 years
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The number and percent of patients with a confirmed response
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5 years
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Best and confirmed ORR based on mRECIST
Time Frame: 5 years
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The number and percent of patients with a confirmed response
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5 years
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Duration of Response (DoR) ≥ 6 months based on localized mRECIST and mRECIST
Time Frame: 5 years
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The number and percent of patients with a DoR ≥ 6 months.
DoR is measured from time of initial response until radiological progression.
Radiological progression is determined by blinded central image review according to localized mRECIST and mRECIST.
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5 years
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Time to Progression (TTP)
Time Frame: 5 years
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TTP defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to progression as per mRECIST
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5 years
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Progression-Free Survival (PFS)
Time Frame: 5 years
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PFS defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to the date of radiological progression or death from any cause.
Radiological progression is determined by blinded central image review according to mRECIST
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5 years
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hepatic Progression-Free Survival (hPFS)
Time Frame: 5 years
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hPFS defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to the date of radiological progression in the liver or death from any cause.
Radiological progression is determined by blinded central image review according to mRECIST
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5 years
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Liver transplantation rate
Time Frame: 5 years
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The number and percent of patients receiving a liver transplant
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5 years
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Liver resection rate
Time Frame: 5 years
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The number and percent of patients undergoing a liver resection
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5 years
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Overall survival (OS)
Time Frame: 5 years
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The median overall survival time
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5 years
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Safety and toxicity by evaluating the number of adverse events and the number of patients with each event
Time Frame: 5 years
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Adverse events classified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
(including clinical and laboratory toxicity)
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5 years
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Liver function during follow-up ALBI score
Time Frame: 5 years
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ALBI score
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5 years
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Liver function during follow-up using MELD score
Time Frame: 5 years
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MELD score
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5 years
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Liver function during follow-up using Child Pugh score
Time Frame: 5 years
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Child Pugh score
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5 years
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Assessment of dosimetry and biodistribution based on quantitative assessment of imaging scans
Time Frame: 5 years
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Correlation between scout and treatment for extrahepatic dose deposition, including lung shunt and digestive shunting of QuiremSpheresTM Holmium-166 Microspheres.
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5 years
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Assessment of dosimetry and biodistribution based on quantitative assessment of imaging scans
Time Frame: 5 years
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Correlation between treatment-based absorbed dose (into the tumor and healthy liver) and clinical outcomes in terms of toxicity and efficacy (i.e.
radiological response).
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5 years
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Assessment of dosimetry and biodistribution based on quantitative assessment of imaging scans
Time Frame: 5 years
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Correlation between scout-based simulated absorbed dose (into the tumor and healthy liver) and the treatment based absorbed dose (into the tumor and healthy liver).
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5 years
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Quality of Life using EQ-5D-5L questionnaire
Time Frame: 1 year
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Patient reported outcome using EQ-5D-5L questionnaire.
The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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, Universitatsklinikum 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T142E3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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