Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT03295006
Eligibility Criteria:
Inclusion Criteria:
* Up to 10 well defined unilobar/bilobar HCC tumor(s) per lobe with at least one tumor ≥3 cm ± PVT
* Liver dominant disease (limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion ≤2cm; any number of lymph node lesions with each individual lesion ≤2 cm).
* Child Pugh stage A or B7.
* BCLC A, B or C.
* Must be male or female, 18 years of age or older.
* Bilirubin ≤2 mg/dL.
* Tumor replacement \<50% of total liver volume assessed by diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI.
* Diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI within 3 months prior to TheraSphere® administration.
* Infusion of 99mTc-MAA in a single arterial location sufficient to cover up to 10 well-defined tumors per lobe ≤ 6 weeks prior to TheraSphere® administration.
* Patients must have received TheraSphere® in a single treatment setting in one or more arterial locations sufficient to cover up to 10 well-defined tumors based on angiography. Subsequent TheraSphere® treatment to the second lobe may occur at least 4 weeks following the initial TheraSphere® treatment.
* For patients receiving a second TheraSphere® treatment bilirubin levels must have been recorded prior to the second treatment
* Patients must have had clinical evaluation (assessment of liver specific AEs) and laboratory evaluation (at least a serum bilirubin level) at baseline.
* Tumor(s), ≥3 cm, measurable by mRECIST and RECIST 1.1 at baseline
Exclusion Criteria:
* Prior external beam radiation treatment to the liver.
* Prior loco-regional liver directed therapy (cTACE, DEB-TACE and SIR-Spheres).
* Prior liver transplantation.
* Whole liver TheraSphere® treatment following prior liver resection.
* TheraSphere administration to ≤2 segments (e.g., radiation segmentectomy).
* Additional active therapy (TACE and treatment with SIR-Spheres) between first TheraSphere treatment and 3 month (90 days) imaging.
* Hepatic vein invasion.
* Diagnosis of disease progression at peri-procedural imaging as compared to the baseline imaging (physician's discretion).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03295006
Study Brief:
Protocol Section:
NCT03295006