This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass microspheres (TheraSphere®) for Hepatocellular Carcinoma (HCC) participants with unresectable Barcelona clinic liver cancer (BCLC) stage A disease.
Participants must have histologically or imaging-confirmed confirmed HCC.
Group 1: Solitary tumor measuring 2-5 cm Or Group 2: 2-3 tumors each ≤ 3 cm in diameter.
No prior therapy to target tumor(s).
Not a candidate for surgical resection or thermal ablation after multidisciplinary assessment.
Macrovascular tumor invasion or infiltrative appearance of hepatocellular carcinoma.
History of severe allergy to iodinated contrast agents despite appropriate premedication.
Is currently receiving any other anti-cancer agents and any previous therapy with a device that uses Y90 as the radioisotope.
Symptomatic heart failure or severe valvular insufficiency.
Parallel
TheraSphere® Yttrium-90 microspheres
DeviceAdministered intra-arterially
Health Related Quality of Life Questionnaires (HRQOL)
Other interventionSurveys administered
Objective Response Rate (ORR) by mRECIST
The objective response rate (ORR) after radiation segmentectomy in participants will be evaluated using a modified Response Evaluation Criteria in Solid Tumors (mRECIST) based on the best tumor response where Complete Response (CR) is defined as the disappearance of any intratumoral arterial enhancement in all target lesions, Partial Response (PR) is defined as a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions, Stable Disease (SD) is defined as any cases that do not qualify for either partial response or progressive disease, and Progressive Disease (PD) is defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started.
Percentage of participants with treatment-related adverse events
The percentage of participants with grade 3 or greater, treatment-related adverse events as classified by NCI Common Terminology Criteria for Adverse Events (CTCAE) will be reported.
Median time from TheraSphere administration to transplant
Transplant-free survival is defined as the time to transplant in months from TheraSphere administration until transplant or death by any cause using the Kaplan-Meier estimator and 90% confidence intervals.
Median time to disease progression
Progression-free survival is defined as the time to tumor progression (in-field, distant intrahepatic, extrahepatic) based on mRECIST in months from TheraSphere administration until disease progression or death by any cause using the Kaplan-Meier estimator and 90% confidence intervals will be reported.
Changes in mean Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) survey results over time
The FACT-Hep is a 45-item self-report instrument developed to assess health-related quality of life (HRQoL) in persons diagnosed with hepatobiliary cancers and consists of the Functional Assessment of Cancer Therapy scale (FACT-G) which is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being and also includes a Hepatobiliary Cancer Subscale (HCS) which consists of an additional 18-items focusing on disease-specific symptoms such as back and stomach pain, gastrointestinal issues, anorexia, weight loss, and jaundice. Each item response score ranges from 0 (not at all) to 4 (very much) with a total score range from 0-180. The higher the score, the better the HRQoL. The change in mean scores over time will be reported.
Changes in mean EuroQol five-dimensional Questionnaire (EQ-5D) survey results over time
EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. Lower scores indicate less issues/problems with that particular health dimension. The change in mean scores over time will be reported.
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