UPCC 04224 Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)

Study Investigating Radioembolization for Liver Cancer

Enrolling By Invitation
18 years - 99 years
All
Phase N/A
120 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable, Liver Cancer
  • Age: 18 years - 99 years
  • Gender: All

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.

This study investigates the use of a medical device containing yttrium-90 for treating liver cancer, specifically Hepatocellular Carcinoma (HCC). The purpose of this study is to evaluate the safety and effectiveness of Eye90 microspheres, which deliver localized radiation therapy directly to liver tumors. This approach is used for patients whose liver cancer cannot be removed through surgery.

Participants in this study will undergo a procedure where Eye90 microspheres are administered to target liver tumors. The treatment involves delivering radiation directly to the cancerous areas in the liver, aiming to minimize damage to healthy tissue. This study will monitor the outcomes and any side effects experienced by the participants.

  • Who can participate: Adults aged 18 and older with confirmed HCC and no extra hepatic disease may be eligible. Participants should have up to 3 liver lesions, with at least one lesion larger than 2 cm, and more than 33% of the liver must be disease-free. They must meet specific health criteria.
  • Study details: Participants will receive Eye90 microspheres in a single session aimed at all lesions. The procedure involves delivering localized radiation to the liver tumors, sparing healthy liver tissue, with the requirement that more than 33% of the liver must be disease-free.
Updated on 04 Mar 2026. Study ID: 24-0461
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