90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
Ochsner Health System
50 participants
Aug 8, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria2
- Pregnant women
- Concurrent malignancy
Interventions
Transarterial Radioembolization
Microwave Ablation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05953961