Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)

Sponsor

ABK Biomedical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05953337

Collaborator

(none)

120

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of subjects with unresectable Hepatocellular Carcinoma (HCC). Eye90 microspheres is a medical device containing yttrium-90 (Y-90), a radioactive material, and provides local radiation brachytherapy for the treatment of liver tumors.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Hepatocellular Carcinoma Non-resectable Liver Cancer	Device: EYE90 Microspheres Treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EYE90 Microspheres Treatment Radioembolization with Eye90 Microspheres	Device: EYE90 Microspheres Treatment Y90 glass microspheres

Arm

Intervention/Treatment

Experimental: EYE90 Microspheres Treatment

Radioembolization with Eye90 Microspheres

Device: EYE90 Microspheres Treatment

Y90 glass microspheres

Outcome Measures

Primary Outcome Measures

Overall response rate (ORR) [6 months]
The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.
Duration of response (DoR) [6 months]
DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR
Incidence of adverse events (AEs) [12 months]
Incidence of AEs, grouped by System Organ Class (SOC) and Preferred Term (PT), relatedness to study treatment/procedure, and severity.
Incidence of serious adverse events (SAEs) [12 months]
Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must have a confirmed diagnosis of HCC by imaging confirmation with Liver Imaging Reporting and Data System (LIRADS) category 5 or confirmation of HCC via biopsy.
No extra hepatic disease.
Up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable by computed tomography (CT), CBCT, or MRI. At least one lesion must be identified as a target lesion as defined by mRECIST.
Maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12 cm with the entire tumor burden expected to be treatable within the perfused volume.
Intent to treat all lesions within a single session.
Hypervascular on CBCT, CT, or MRI.
Evidence that > 33% of the total liver volume is disease-free and will be spared Eye90 treatment.
Life expectancy of ≥ 6 months.
≥ 18 years old at the time of informed consent

Exclusion Criteria:

Platelet count <50,000/microliter or prothrombin (PT) activity > 50% normal.
Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical management must be excluded).
INR > 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
ALT > 5x upper limit.
AST > 5x upper limit.
Bilirubin ≥ 2.0 mg/dL.
eGFR ≤ 50 mL/min/BSA.
Macrovascular invasion.
Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater.
Estimated lung dose > 30 Gy as calculated using the lung shunt fraction and partition model.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

ABK Biomedical

Investigators

Principal Investigator: Andrew Kennedy, MD, Director, Radiation Oncology Research at Sarah Cannon
Study Director: Aravind Arepally, MD, ABK Biomedical, Inc