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

Not Applicable

Recruiting

• Conditions: Carcinoma, Hepatocellular
• Interventions: Device: Therasphere 90Y; Device: Microwave Ablation

• Registration Number: NCT05953961
• Lead Sponsor: Ochsner Health System

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Study Start: 2023-08-08
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14
• Primary Completion: 2026-08
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therasphere Transarterial Radioembolization	Therasphere 90Y	Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.
Microwave Ablation	Microwave Ablation	Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin \> 5mm.

Primary Outcome Measures

Name	Time	Method
Disease Progression	1-year	Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ochsner Main Campus; 🇺🇸 New Orleans, Louisiana, United States