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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P200029 S011/ PAS001 |
| Date Original Protocol Accepted |
04/10/2026
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| Date Current Protocol Accepted |
04/10/2026
|
| Study Name |
ADVANCE-MCD Post-Approval Study
|
| Device Name |
TheraSphere
|
| Clinical Trial Number(s) |
NCT02582034
NCT03295006
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Study Design:
Open label, single arm, prospective, US study to evaluate the safety and effectiveness of TheraSphere Microspheres administration using multicompartment dosimetry in patients with unresectable HCC.
Primary Objective:
To evaluate the safety of TheraSphere Microspheres treatment based on multicompartment dosimetry for pretreatment planning and post-treatment evaluation.
Secondary Objective:
To evaluate the effectiveness of the treatment procedure.
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| Study Population |
Patients with solitary (1-8 cm diameter) unresectable hepatocellular carcinoma (HCC), Child-Pugh Score A cirrhosis, well-compensated liver function, no macrovascular invasion, and good performance status.
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| Sample Size |
Number of subjects:
140 evaluable patients
Assumptions for sample size estimation:
A formal sample size computation, based on a pre-defined statistical hypothesis test, will not be performed for this study. However, a minimum of 140 evaluable patients are considered to provide sufficiently narrow 95% confidence intervals (CIs) for the number of patients with REILD Grade greater than or equal to 3 up to 4 months.
Assuming an expected REILD Grade greater than or equal to 3 rate of 5%, the two-sided 95% CI would be 2.0% to 10.0% with 140 evaluable patients using the method of Clopper-Pearson.
The study will be considered successful if the upper bound of the two-sided 95% CI for the REILD Grade greater than or equal to 3 rate is less than 10% up to month 4 after any TheraSphere Microspheres administration performed before progression.
To account for an anticipated dropout rate of 5%, approximately 147 patients will be enrolled to ensure that at least 140 evaluable patients are available for primary safety analysis.
Number of sites:
10 sites
Sites location:
US
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| Key Study Endpoints |
Safety Endpoints
Primary:
The rate of Radioembolization Induced Liver Disease (REILD) Grade greater than or equal to 3 occurring up to 4 months after any TheraSphere Microspheres treatment administration before progression.
Secondary:
-Number of device and/or procedure# related Adverse Events (AEs) and Serious Adverse Events (SAEs)
-Change from baseline in Albumin Bilirubin (ALBI) score.
-The most severe grade of hepatoxicity after RE occurring during the 13-month follow-up period
Effectiveness Endpoints
Secondary:
-Objective Response Rate (ORR) evaluated by localized mRECIST and mRECIST criteria
-Duration of Response (DoR) evaluated by localized mRECIST and mRECIST criteria
-Number of patients that become eligible for liver transplantation or liver resection
-Histopathology evaluation for patients who had surgery
-Overall survival
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| Follow-up Visits and Length of Follow-up |
The study duration for each patient is expected to be approximately 14 months (1 month screening and 13 months follow-up).
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