About this trial
This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass microspheres (TheraSphere®) for Hepatocellular Carcinoma (HCC) participants with unresectable Barcelona clinic liver cancer (BCLC) stage A disease.
Eligibility criteria
Qualifiers
Participants must have histologically or imaging-confirmed confirmed HCC.
Group 1: Solitary tumor measuring 2-5 cm Or Group 2: 2-3 tumors each ≤ 3 cm in diameter.
No prior therapy to target tumor(s).
Not a candidate for surgical resection or thermal ablation after multidisciplinary assessment.
Disqualifiers
Macrovascular tumor invasion or infiltrative appearance of hepatocellular carcinoma.
History of severe allergy to iodinated contrast agents despite appropriate premedication.
Is currently receiving any other anti-cancer agents and any previous therapy with a device that uses Y90 as the radioisotope.
Symptomatic heart failure or severe valvular insufficiency.
Trial design
Treatments tested in this trial
- TheraSphere® Yttrium-90 microspheres
- Health Related Quality of Life Questionnaires (HRQOL)
Treatment groups
Locations
1Sponsors and collaborators
University of California, San Francisco
Lead sponsor