Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).

Official Title
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Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Hepatocellular Carcinoma: A Pilot Study

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria. The cancer is unresectable. All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Age 18 years or older. Able to understand informed consent. Exclusion Criteria: Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: single TheraSphere administration; or cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments. Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow. Previous radiation therapy to the lungs and/or to the upper abdomen Pregnancy Symptomatic lung disease. Significant extrahepatic disease representing an imminent life-threatening outcome. Active uncontrolled infection Any pre-treatment laboratory findings within 30 days of treatment demonstrating: Aspartate or alanine aminotransferase level greater than 5 times upper normal limit. Serum bilirubin greater than 2 mg/dl Infiltrative tumor on imaging Tumor volume greater than 70% of liver volume Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yttrium-90 liver radioembolization<br>Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) | Device: Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)<br>* Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT: up to 5 lesions at baseline and sum longest diameters (SLD). Complete Response (CR), -Target Lesions: Disappearance of all target lesions. -Non-target Lesions: disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) < %30 decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) -Target Lesions: > 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy | 6 months |