Carcinoma, Hepatocellular
Conditions
Keywords
Yttrium-90, Hypoalbuminemia
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.
Interventions
DEVICETherasphere 90Y
Transarterial Radioembolization
DEVICEMicrowave Ablation
Microwave Ablation
Sponsors
Boston Scientific Corporation
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Progression | 1-year | Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Response Evaluation Criteria in Solid Tumors modified for HCC | 60 - 120 days post-treatment | Durable target tumor response rate |
| Time to Retreatment | 1 year | Duration of time following the first cycle treatment until the targeted tumor requires additional treatment |
| Duration of Response | 1 year | Duration of time after first cycle treatment the target tumor continues to respond to treatment |
Countries
United States
Contacts
Primary ContactKen Bode
Backup ContactAmy Riehm
Outcome results
None listed