90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

Description

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.

Conditions

Carcinoma, Hepatocellular

Study Overview

Study Details

Study overview

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.

Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

Condition
Carcinoma, Hepatocellular
Intervention / Treatment

-

Contacts and Locations

New Orleans

Ochsner Main Campus, New Orleans, Louisiana, United States, 70121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Pregnant women
  • * Concurrent malignancy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ochsner Health System,

Ari Cohen, MD, PRINCIPAL_INVESTIGATOR, Ochsner Health

Study Record Dates

2027-01