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

64 Participants
are divided into 2 treatment groups

Locations

1
University of California, San Francisco94143, San FranciscoCalifornia, United States

Sponsors and collaborators

University of California, San Francisco

Lead sponsor