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®).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
University of California San Francisco
San Francisco, California, United States
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
Time frame: 6 months
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
Time frame: 6 months
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