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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953337
• Other study ID #: ABK-CA-PROT-85
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: ABK Biomedical
• Contact: ABK Biomedical
• Phone: +1.902.442.4009
• Email: safety[@]abkbiomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hepatocellular Carcinoma Non-resectable
• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• EYE90 Microspheres Treatment
Y90 glass microspheres

Locations

Country	Name	City	State
United States	Beth Israel Deaconess	Boston	Massachusetts
United States	Charlotte Radiology	Charlotte	North Carolina
United States	University of Louisville	Louisville	Kentucky
United States	HCA Healthcare Research Institute (Sarah Cannon)	Nashville	Tennessee
United States	University of California - Irvine	Orange	California
United States	SSM Health Saint Louis University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
ABK Biomedical

Country where clinical trial is conducted

United States, 

Outcome

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