90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

Study Overview
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Brief Summary
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This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.

Detailed Description
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This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin < 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy. The study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.

Official Title
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Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Device: Therasphere 90Y
* Device: Microwave Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines Eastern Cooperative Oncology Group score 0 - 1 Child-Pugh A - B Bilirubin < 2.5 mg/dL Creatinine < 2.0 mg/dL No prior liver-directed therapy or systemic therapy for HCC Solitary, unresectable HCC ≤ 3cm Albumin level < 3.4 g/dL at HCC diagnosis Tumor anatomical location and angiosome amendable to MWA and 90Y Exclusion Criteria: Pregnant women Concurrent malignancy

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Therasphere Transarterial Radioembolization<br>Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion. | Device: Therasphere 90Y<br>* Transarterial Radioembolization<br>|
| Active Comparator: Microwave Ablation<br>Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin > 5mm. | Device: Microwave Ablation<br>* Microwave Ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Progression | Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Response Evaluation Criteria in Solid Tumors modified for HCC | Durable target tumor response rate | 60 - 120 days post-treatment | 
| Time to Retreatment | Duration of time following the first cycle treatment until the targeted tumor requires additional treatment | 1 year | 
| Duration of Response | Duration of time after first cycle treatment the target tumor continues to respond to treatment | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yttrium-90, Hypoalbuminemia