Hepatocellular CarcinomaNCT07110233
Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma
A study testing TheraSphere® Yttrium-90 microspheres and Health Related Quality of Life Questionnaires (HRQOL) in people with Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Hepatocellular Cancer
- What is being tested?
- TheraSphere® Yttrium-90 microspheres and Health Related Quality of Life Questionnaires (HRQOL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤5 X institutional upper limit of normal.
- alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤5 X institutional upper limit of normal.
- Creatinine Glomerular filtration rate (GFR) > 30 ml/min.
- Child-Pugh score ≤ B7
- Albumin-bilirubin (ALBI) score 1-2
- Participants who have received systemic therapy for HCC will be excluded from the trial.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Who cannot join
- 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.
- Symptomatic ascites.
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- 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.
- Pregnant women are excluded from this study because TheraSphere emits radiation with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSphere, breastfeeding should be discontinued if the mother is treated with TheraSphere.
- Lung-shunt fraction (LSF) resulting in anticipated lung dose of >30 Gray (Gy).
- History of sphincterotomy, biliary-enteric anastomosis, or other biliary tract instrumentation. Note: Prior cholecystectomy with or without bile duct exploration is permitted.
- Tumor perfused by extrahepatic collateral arteries.
- Prior partial hepatectomy.
- Psychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirements.
- History of or current extrahepatic cancer.
- Pulmonary insufficiency (defined by an arterial oxygen pressure (Pa,O2) of < 60 mmHg, or oxygen saturation (Sa,O2) of < 90%).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Maya Aslam, 415-514-8987, Maya.Aslam@ucsf.edu
Ryan Lokken, MD
About this study
Official title: Prospective Phase 2 Trial of Yttrium-90 Radiation Segmentectomy for Unresectable Hepatocellular Carcinoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- TheraSphere® Yttrium-90 microspheres, Health Related Quality of Life Questionnaires (HRQOL)
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphere® Yttrium-90 microspheresDevice
Also called TheraSphere®, Yttrium-90 microspheres, Microspheres Radionuclide
Administered intra-arterially
Health Related Quality of Life Questionnaires (HRQOL)Other
Also called HRQOL Questionnaires
Surveys administered
| Study group | Role | What they receive |
|---|---|---|
| Group 1. TheraSphere® Yttrium-90 microspheres | Experimental | Participants 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. Receives: Device: TheraSphere® Yttrium-90 microspheres; Other: Health Related Quality of Life Questionnaires (HRQOL) |
| Group 2. TheraSphere® Yttrium-90 microspheres | Experimental | Participants 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. Receives: Device: TheraSphere® Yttrium-90 microspheres; Other: Health Related Quality of Life Questionnaires (HRQOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) by mRECIST
The objective response rate (ORR) after radiation segmentectomy in participants will be evaluated using a modified Response Evaluation Criteria in Solid Tumors (mRECIST) based on the best tumor response where Complete Response (CR) is defined as the disappearance of any intratumoral arterial enhancement in all target lesions, Partial Response (PR) is defined as a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions, Stable Disease (SD) is defined as any cases that do not qualify for either partial response or progressive disease, and Progressive Disease (PD) is defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started.
Measured: Up to 6 months
Percentage of participants with treatment-related adverse events
The percentage of participants with grade 3 or greater, treatment-related adverse events as classified by NCI Common Terminology Criteria for Adverse Events (CTCAE) will be reported.
Measured: Up to 6 months
Secondary outcomes (8)
Median time from TheraSphere administration to transplant
Transplant-free survival is defined as the time to transplant in months from TheraSphere administration until transplant or death by any cause using the Kaplan-Meier estimator and 90% confidence intervals.
Measured: Up to 3 years
Median time to disease progression
Progression-free survival is defined as the time to tumor progression (in-field, distant intrahepatic, extrahepatic) based on mRECIST in months from TheraSphere administration until disease progression or death by any cause using the Kaplan-Meier estimator and 90% confidence intervals will be reported.
Measured: Up to 3 years
Changes in mean Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) survey results over time
The FACT-Hep is a 45-item self-report instrument developed to assess health-related quality of life (HRQoL) in persons diagnosed with hepatobiliary cancers and consists of the Functional Assessment of Cancer Therapy scale (FACT-G) which is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being and also includes a Hepatobiliary Cancer Subscale (HCS) which consists of an additional 18-items focusing on disease-specific symptoms such as back and stomach pain, gastrointestinal issues, anorexia, weight loss, and jaundice. Each item response score ranges from 0 (not at all) to 4 (very much) with a total score range from 0-180. The higher the score, the better the HRQoL. The change in mean scores over time will be reported.
Measured: Up to 6 months
Changes in mean EuroQol five-dimensional Questionnaire (EQ-5D) survey results over time
EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. Lower scores indicate less issues/problems with that particular health dimension. The change in mean scores over time will be reported.
Measured: Up to 6 months
Best observed tumor response by mRECIST.
Best imaging response at 1 year will be determined based on mRECIST criteria among imaging follow up within 1 year of treatment.
Measured: Up to 1 year
Proportion of participants on an active liver transplant waitlist who receive a transplant
Participants status on the transplant list will be recorded and the proportion of them among all enrolled participants will be reported.
Measured: Up to 3 years
Proportion of participants requiring additional therapies
The proportion of participants that need subsequent loco-regional therapies as deemed clinically indicated after TheraSphere administration will be reported.
Measured: Up to 3 years
Proportion of participants with Complete pathologic response (CPN)
The proportion of participants who underwent a liver transplant and demonstrated CPN post-transplant will be reported.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Oct 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Lokken, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110233
- Sponsor's protocol ID
- RLOKKEN-A
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase 2 Trial of Yttrium-90 Radiation Segmentectomy for Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07110233
- Acronym / sponsor ID
- RLOKKEN-A
- Conditions
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Hepatocellular Cancer, Hepatocellular Carcinoma Non-resectable
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1. TheraSphere® Yttrium-90 microspheres | Experimental | Device: TheraSphere® Yttrium-90 microspheres, Other: Health Related Quality of Life Questionnaires (HRQOL)Participants 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. |
| Group 2. TheraSphere® Yttrium-90 microspheres | Experimental | Device: TheraSphere® Yttrium-90 microspheres, Other: Health Related Quality of Life Questionnaires (HRQOL)Participants 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraSphere® Yttrium-90 microspheresAlso: TheraSphere®, Yttrium-90 microspheres, Microspheres RadionuclideAdministered intra-arterially | Device | Group 1. TheraSphere® Yttrium-90 microspheres, Group 2. TheraSphere® Yttrium-90 microspheres |
| Health Related Quality of Life Questionnaires (HRQOL)Also: HRQOL QuestionnairesSurveys administered | Other | Group 1. TheraSphere® Yttrium-90 microspheres, Group 2. TheraSphere® Yttrium-90 microspheres |
Primary outcome
Objective Response Rate (ORR) by mRECIST
Time frame: Up to 6 months
The objective response rate (ORR) after radiation segmentectomy in participants will be evaluated using a modified Response Evaluation Criteria in Solid Tumors (mRECIST) based on the best tumor response where Complete Response (CR) is defined as the disappearance of any intratumoral arterial enhancement in all target lesions, Partial Response (PR) is defined as a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions, Stable Disease (SD) is defined as any cases that do not qualify for either partial response or progressive disease, and Progressive Disease (PD) is defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started.
Percentage of participants with treatment-related adverse events
Time frame: Up to 6 months
The percentage of participants with grade 3 or greater, treatment-related adverse events as classified by NCI Common Terminology Criteria for Adverse Events (CTCAE) will be reported.
8 secondary outcomes
Median time from TheraSphere administration to transplant
Time frame: Up to 3 years
Median time to disease progression
Time frame: Up to 3 years
Changes in mean Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) survey results over time
Time frame: Up to 6 months
Changes in mean EuroQol five-dimensional Questionnaire (EQ-5D) survey results over time
Time frame: Up to 6 months
Best observed tumor response by mRECIST.
Time frame: Up to 1 year
Proportion of participants on an active liver transplant waitlist who receive a transplant
Time frame: Up to 3 years
Proportion of participants requiring additional therapies
Time frame: Up to 3 years
Proportion of participants with Complete pathologic response (CPN)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Lokken, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSphere® Yttrium-90 microspheres and Health Related Quality of Life Questionnaires (HRQOL) in people with Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Aslam ((415) 514-8987, Maya.Aslam@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) by mRECIST (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.