Clinical trial NCT05953961: 90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
Official title: Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Yttrium-90
Hypoalbuminemia
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2023-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease Progression
timeFrame: 1-year
Secondary outcomes:
measure: Target Response Evaluation Criteria in Solid Tumors modified for HCC
timeFrame: 60 - 120 days post-treatment
measure: Time to Retreatment
timeFrame: 1 year
measure: Duration of Response
timeFrame: 1 year
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Main Campus
state: Louisiana
Study officials:
affiliation: Ochsner Health
name: Ari Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: