Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT07110233
- Status
- Not Yet Recruiting
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Conditions
- Hepatocellular Cancer
- Hepatocellular Carcinoma
- Hepatocellular Carcinoma Non-resectable
- Unresectable Hepatocellular Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- TheraSphere® Yttrium-90 microspheres — DEVICEAdministered intra-arterially
- Health Related Quality of Life Questionnaires (HRQOL) — OTHERSurveys administered
Study Details
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.
Key Dates
- Start date
- May 1, 2026
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 64 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Group 1. TheraSphere® Yttrium-90 microspheresParticipants with a single tumor measuring 2-5 cm will receive one dose of TheraSphere® \>250 Gy, and ideally \> 400 Gy at the treating physician's discretion. Participants will be monitored for safety and complete quality of life questionnaires.
- Experimental: Group 2. TheraSphere® Yttrium-90 microspheresParticipants with 2-3 tumors ≤ 3 cm in diameter (T2 disease) will receive one dose of TheraSphere® \>250 Gy, and ideally \> 400 Gy at the treating physician's discretion. Participants will be monitored for safety and complete quality of life questionnaires.
Primary Outcome Measure
Objective Response Rate (ORR) by mRECIST [ Time Frame: Up to 6 months ]
Central Contacts
- Maya Aslam(415) 514-8987
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | Ryan Lokken, MD (PRINCIPAL_INVESTIGATOR) |
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