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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-08

Study Completion Date

2027-01-31

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.

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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.

Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therasphere Transarterial Radioembolization

Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.

Group Type ACTIVE_COMPARATOR

Therasphere 90Y

Intervention Type DEVICE

Transarterial Radioembolization

Microwave Ablation

Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin \> 5mm.

Group Type ACTIVE_COMPARATOR

Microwave Ablation

Intervention Type DEVICE

Microwave Ablation

Interventions

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Therasphere 90Y

Transarterial Radioembolization

Intervention Type DEVICE

Microwave Ablation

Intervention Type DEVICE

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