Clinical trial · Interventional
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)
NCT05953337CI-TRIAL-00104519active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma Non-resectable | — | UNRESOLVED | — |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EYE90 Microspheres Treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EYE90 Microspheres Treatment
- description
- Radioembolization with Eye90 Microspheres
- interventionNames
- Device: EYE90 Microspheres Treatment
Primary outcomes (4)
- measure
- Overall response rate (ORR)
- timeFrame
- 6 months
- description
- The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.
- measure
- Duration of response (DoR)
- timeFrame
- 6 months
- description
- DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.