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Trial Title:
90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
NCT ID:
NCT05953961
Condition:
Carcinoma, Hepatocellular
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Hypoalbuminemia
Conditions: Keywords:
Yttrium-90
Hypoalbuminemia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Therasphere 90Y
Description:
Transarterial Radioembolization
Arm group label:
Therasphere Transarterial Radioembolization
Intervention type:
Device
Intervention name:
Microwave Ablation
Description:
Microwave Ablation
Arm group label:
Microwave Ablation
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ochsner Main Campus
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ken Bode
Email:
ken.bode@ochsner.org
Start date:
August 8, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
Ochsner Health System
Agency class:
Other
Collaborator:
Agency:
Boston Scientific Corporation
Agency class:
Industry
Source:
Ochsner Health System
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05953961
