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

Carcinoma, Hepatocellular Clinical Trial

— REALM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953961
• Other study ID #: 2023.090
• Secondary ID: Sponsored Resear
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: January 2027

Study information

• Verified date: July 2023
• Source: Ochsner Health System
• Contact: Ken Bode
• Phone: 5048421936
• Email: ken.bode[@]ochsner.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hypoalbuminemia

Intervention

Device:
• Therasphere 90Y
Transarterial Radioembolization
• Microwave Ablation
Microwave Ablation

Locations

Country	Name	City	State
United States	Ochsner Main Campus	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Ochsner Health System	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Progression	Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm	1-year
Secondary	Target Response Evaluation Criteria in Solid Tumors modified for HCC	Durable target tumor response rate	60 - 120 days post-treatment
Secondary	Time to Retreatment	Duration of time following the first cycle treatment until the targeted tumor requires additional treatment	1 year
Secondary	Duration of Response	Duration of time after first cycle treatment the target tumor continues to respond to treatment	1 year