Comparing two treatments for small liver cancer in patients with low albumin levels
Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
This study is testing which treatment, either 90-Yttrium Therasphere or microwave ablation, works better for people with small liver cancer and low albumin levels to see which one helps keep the cancer from getting worse in the first year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ochsner Health System Academic / other |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT05953961 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of 90-Yttrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA) in patients diagnosed with small, early-stage hepatocellular carcinoma (HCC) who also have hypoalbuminemia. The study focuses on patients with a single tumor of 3 cm or less and aims to determine which treatment lowers the risk of disease progression within the first year after diagnosis. Participants will be randomly assigned to receive either 90Y or MWA as their initial treatment, followed by standard care. The trial will enroll 50 participants and will track their outcomes over a one-year observational period.
Who should consider this trial
Good fit: Ideal candidates include patients with a new diagnosis of solitary, unresectable hepatocellular carcinoma ≤ 3 cm and hypoalbuminemia.
Not a fit: Patients with concurrent malignancies or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with small hepatocellular carcinoma and low albumin levels.
How similar studies have performed: While there have been studies on both 90Y and MWA separately, this specific comparison in the context of hypoalbuminemia is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Orleans, Louisiana
- Ochsner Main Campus — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Ari Cohen, MD — Ochsner Health
- Study coordinator: Ken Bode
- Email: ken.bode@ochsner.org
- Phone: 5048421936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.