University of California, San Francisco
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.
PRIMARY OBJECTIVES: I. To evaluate the objective response rate (ORR) after radiation segmentectomy in participants with BCLC Stage A HCC and 1) a single solitary tumor measuring 2-5 centimeters (cm) and 2) 2 or 3 lesions each ≤ 3 cm. II. To assess the safety of radiation segmentectomy. SECONDARY OBJECTIVES: I. To evaluate transplant-free survival. II. To evaluate progression-free survival. III. To evaluate the quality of life of participants. IV. To evaluate the best imaging response. V. To determine the proportion of participants who remain active on the wait list for liver transplant…
Inclusion Criteria: 1. Participants must have histologically or imaging-confirmed confirmed HCC. 2. Group 1: Solitary tumor measuring 2-5 cm Or Group 2: 2-3 tumors each ≤ 3 cm in diameter. 3. No prior therapy to target tumor(s). 4. Not a candidate for surgical resection or thermal ablation after multidisciplinary assessment. 5. Age ≥22 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1. 7. Demonstrated adequate organ function as defined below: 1. Total bilirubin ≤3.0 mg/dL, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.…
Administered intra-arterially
Surveys administered
Arctuva estimate
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