Trials / Not Yet Recruiting
Not Yet RecruitingNCT07110233
Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma
Prospective Phase 2 Trial of Yttrium-90 Radiation Segmentectomy for Unresectable Hepatocellular Carcinoma
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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 and eventually are transplanted. VI. The evaluate the number of participants that need additional treatment after TheraSphere® administration. VII. Complete pathologic response (CPN) on liver explants among participants who underwent liver transplant. Participants will undergo a single TheraSphere® administration and followed for quality-of-life outcomes and survival for up to 3 years after treatment. Participants will be censored at time of future transplant or if death occurs at any time after treatment.
Conditions
- Hepatocellular Carcinoma
- Unresectable Hepatocellular Carcinoma
- Hepatocellular Cancer
- Hepatocellular Carcinoma Non-resectable
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TheraSphere® Yttrium-90 microspheres | Administered intra-arterially |
| OTHER | Health Related Quality of Life Questionnaires (HRQOL) | Surveys administered |
Timeline
- Start date
- 2026-05-01
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2025-08-07
- Last updated
- 2026-01-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07110233. Inclusion in this directory is not an endorsement.