Hepatocellular CarcinomaNCT05953337
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
A study testing EYE90 Microspheres Treatment in people with Hepatocellular Carcinoma and Hepatocellular Carcinoma Non-resectable, run by ABK Biomedical at 22 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable, Liver Cancer
- What is being tested?
- EYE90 Microspheres Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 21 Sep 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States21 sites
AdventHealth Radiation Oncology at Altamonte Springs
Altamonte Springs, Florida, 32701
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Hospital
Atlanta, Georgia, 30309
Beth Israel Deaconess
Boston, Massachusetts, 02215
Charlotte Radiology
Charlotte, North Carolina, 28202
Northwestern University Memorial Hospital
Chicago, Illinois, 60611
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612
University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri, 65212
University of Iowa Health Care
Iowa City, Iowa, 52242
University of Louisville
Louisville, Kentucky, 40202
Miami Cardiac and Vascular Institute at Baptist Hospital Miami
Miami, Florida, 33176
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
HCA Healthcare Research Institute (Sarah Cannon)
Nashville, Tennessee, 37203
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10065
University of California - Irvine
Orange, California, 92867
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84112
Inland Imaging
Spokane, Washington, 99203
SSM Health Saint Louis University
St Louis, Missouri, 63104
The University of Arizona Cancer Center
Tucson, Arizona, 85719
Canada1 site
Vancouver Coastal Health Research Institution (VCHRI)
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)
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.
- Being tested
- EYE90 Microspheres Treatment
- Keywords
- Hepatocellular Carcinoma, Liver Cancer, Liver Diseases, Internal radiation brachytherapy, Radioembolization, Y90, Yttrium-90, Eye90 microspheres
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYE90 Microspheres TreatmentDevice
Y90 glass microspheres
| Study group | Role | What they receive |
|---|---|---|
| EYE90 Microspheres Treatment | Experimental | Radioembolization with Eye90 Microspheres Receives: Device: EYE90 Microspheres Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.
Measured: 6 months
Duration of response (DoR)
DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR
Measured: 6 months
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.
Measured: 12 months
Incidence of serious adverse events (SAEs)
Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start21 Sep 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ABK Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Kennedy, MD, Principal investigator, Director, Radiation Oncology Research at Sarah CannonAmmar Sarwar, MD, Principal investigator, Director of Radiation Oncology Research, Beth Israel Deaconess Medical CenterAravind Arepally, MD, Study director, ABK Biomedical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953337
- Sponsor's protocol ID
- ABK-CA-PROT-85
- Status last verified
- Mar 2026
- First submitted
- 12 Jul 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT05953337
- Acronym / sponsor ID
- ABK-CA-PROT-85
- Keywords
- Hepatocellular Carcinoma, Liver Cancer, Liver Diseases, Internal radiation brachytherapy, Radioembolization, Y90, Yttrium-90, Eye90 microspheres
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ABK BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EYE90 Microspheres Treatment | Experimental | Device: EYE90 Microspheres TreatmentRadioembolization with Eye90 Microspheres |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYE90 Microspheres TreatmentY90 glass microspheres | Device | EYE90 Microspheres Treatment |
Primary outcome
Overall response rate (ORR)
Time frame: 6 months
The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.
Duration of response (DoR)
Time frame: 6 months
DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR
Incidence of adverse events (AEs)
Time frame: 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)
Time frame: 12 months
Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Kennedy, MD principal investigator
Director, Radiation Oncology Research at Sarah Cannon
Ammar Sarwar, MD principal investigator
Director of Radiation Oncology Research, Beth Israel Deaconess Medical Center
Aravind Arepally, MD study director
ABK Biomedical, Inc
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EYE90 Microspheres Treatment in people with Hepatocellular Carcinoma and Hepatocellular Carcinoma Non-resectable, run by ABK Biomedical at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.