Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma
United States64 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Age ≥22 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1.
✓. Demonstrated adequate organ function as defined below:
✓. Total bilirubin ≤3.0 mg/dL, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.
Exclusion criteria
✕. 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.
✕. Symptomatic pulmonary hypertension or lung disease.
What they're measuring
1
Objective Response Rate (ORR) by mRECIST
Timeframe: Up to 6 months
2
Percentage of participants with treatment-related adverse events
✕. Severe uncontrolled coagulopathy International Normalized Ratio (INR) ≥ 3.0 or Platelet ≤ 20,000.
✕. Main vein thrombosis (portal vein, both bland and tumor thrombus). Note: Less than lobar portal vein thrombosis is allowable only if the thrombus is bland.