Hepatocellular Carcinoma (HCC)ADVANCE-MCDNCT07669727
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
An observational study of Hepatocellular Carcinoma (HCC), run by Boston Scientific Corporation.
Trial summary
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere. TheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- TheraSphere
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to May 2029
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from U.S. centers that are participating in the trial. Patients at these centers who are planning to undergo TheraSphere Microsphere treatment for their hepatocellular carincoma will be considered for this study.
Who may be able to join
- TheraSphere Microspheres treatment determined as the optimal therapy
- Have unresectable solitary HCC
- Treatment Naïve
- ECOG 0 or 1
- Adequate liver function
- Adequate renal and marrow function
- Negative pregnancy test and/or adequate contraception for the patient and his/her sexual partner
Who cannot join
- Macrovascular invasion
- Extrahepatic metastases
- Previous or current ascites/encephalopathy
- Previous liver radiation, TACE, or systemic therapy for the disease
- History of organ allograft including bone marrow
- Any significant comorbities or contraindications to TheraSphere
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
TheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into "compartments" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.
Traditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- TheraSphere
- Keywords
- Hepatocellular Carcinoma, TheraSphere, multicompartment dosimetry, Radioembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphereDevice
Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
| Study group | Role | What they receive |
|---|---|---|
| Unresectable Hepatocellular Carcinoma | Patients with unresectable hepatocellular carcinoma (HCC) with tumor sizes 1-8cm. Patients will be candidates for TheraSphere Microspheres and planning to undergo the procedure as part of their treatment plan. Receives: Device: TheraSphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The rate of Radioembolization Induced Liver Disease (REILD) Grade ≥3 occurring up to 4 months after any TheraSphere Microspheres treatment administration before progression.
Measured: 4 months
Secondary outcomes (8)
Secondary Safety Endpoint
Number of device- and/or procedure-related adverse events (AEs) and serious adverse events (SAEs), measured by count (number of events).
Measured: 13 months
Secondary Safety Endpoint
Change from baseline in Albumin Bilirubin (ALBI) score, measured using the ALBI index.
Measured: 13 months
Secondary Safety Endpoint
Most severe grade of hepatotoxicity following radioembolization, assessed using CTCAE grading criteria.
Measured: 13 months
Secondary Effectiveness Endpoint
Objective Response Rate (ORR) as assessed by localized mRECIST criteria.
Measured: 13 months
Secondary Effectiveness Endpoint
Duration of Response (DoR) evaluated by localized mRECIST and mRECIST criteria.
Measured: 13 months
Secondary Effectiveness Endpoint
Number of patients who become eligible for liver transplantation or liver resection following treatment, measured by total count (number of patients).
Measured: 13 months
Secondary Effectiveness Endpoint
Histopathologic response assessment in patients who undergo surgical resection, collected through descriptive and categorial data points.
Measured: 13 months
Secondary Effectiveness Endpoint
Overall Survival (OS), defined as the time from treatment initiation to death from any cause, measured in months.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startJan 2027 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669727
- Sponsor's protocol ID
- S10104
- Acronym
- ADVANCE-MCD
- Status last verified
- Sep 2026
- First submitted
- 29 May 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning
- ClinicalTrials.gov ID
- NCT07669727
- Acronym / sponsor ID
- ADVANCE-MCD / S10104
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular Carcinoma, TheraSphere, multicompartment dosimetry, Radioembolization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 25 Jun 2026 (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.
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
TheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into "compartments" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.
Traditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable Hepatocellular Carcinoma | – | Device: TheraSpherePatients with unresectable hepatocellular carcinoma (HCC) with tumor sizes 1-8cm. Patients will be candidates for TheraSphere Microspheres and planning to undergo the procedure as part of their treatment plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from U.S. centers that are participating in the trial. Patients at these centers who are planning to undergo TheraSphere Microsphere treatment for their hepatocellular carincoma will be considered for this study.
Key inclusion criteria (7 listed)
- TheraSphere Microspheres treatment determined as the optimal therapy
- Have unresectable solitary HCC
- Treatment Naïve
- ECOG 0 or 1
- Adequate liver function
Key exclusion criteria (6 listed)
- Macrovascular invasion
- Extrahepatic metastases
- Previous or current ascites/encephalopathy
- Previous liver radiation, TACE, or systemic therapy for the disease
- History of organ allograft including bone marrow
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 |
|---|---|---|
| TheraSpherePlacement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry | Device | Unresectable Hepatocellular Carcinoma |
Primary outcome
Primary Safety Endpoint
Time frame: 4 months
The rate of Radioembolization Induced Liver Disease (REILD) Grade ≥3 occurring up to 4 months after any TheraSphere Microspheres treatment administration before progression.
8 secondary outcomes
Secondary Safety Endpoint
Time frame: 13 months
Secondary Safety Endpoint
Time frame: 13 months
Secondary Safety Endpoint
Time frame: 13 months
Secondary Effectiveness Endpoint
Time frame: 13 months
Secondary Effectiveness Endpoint
Time frame: 13 months
Secondary Effectiveness Endpoint
Time frame: 13 months
Secondary Effectiveness Endpoint
Time frame: 13 months
Secondary Effectiveness Endpoint
Time frame: 13 months
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 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by Boston Scientific Corporation.
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 7 inclusion and 6 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Natalie Lydon, MHA (+1 (612) 240-6364, natalie.lydon@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 4 months). 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 1 Oct 2026.