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

Ochsner Health System

Status: Enrolling

Conditions: Carcinoma, Hepatocellular

Treatments: Device: Therasphere 90Y; Device: Microwave Ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05953961

Sponsored Research Agreement (Other Grant/Funding Number)

2023.090

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Therasphere Transarterial Radioembolization

Active Comparator group

Description:

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

Treatment:

Device: Therasphere 90Y

Microwave Ablation

Active Comparator group

Description:

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

Treatment:

Device: Microwave Ablation