To evaluate the efficacy and safety of TheraSphereTM yttrium \[90Y\] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
TheraSphere™ Yttrium-90 Glass Microspheres TheraSphere™ is steam sterilized and supplied in 6 standard dose sizes: 3 GBq, 5 GBq, 7 GBq, 10 GBq, 15 GBq, 20 GBq. Custom dose sizes are also available in 0.5 GBq increments between 3 and 20 GBq. TheraSphereTM is supplied with the following accessories: Administration Set Administration Accessory Kit
conventional Transarterial Chemoembolization(cTACE) is comprised of an anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). The choice of agent(s) to be used is per usual local site practice. Chemotherapy agents can be as a single agent or used in combination, as per local practice.
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Time to progression (TTP)
Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST
Time frame: through study completion, an average of 18 months
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
Time frame: within 60 days post treatment
Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area)
Time frame: through study completion, an average of 18 months
Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area)
Time frame: through study completion, an average of 18 months
Confirmed ORR according to mRECIST
Time frame: through study completion, an average of 18 months
OS (Overall Survival)
Time frame: through study completion, an average of 18 months
Safety assessed using NCI-CTCAE v 5.0
Safety assess: to standardize reporting, the National Cancer Institute Common Terminology Criteria (NCI CTCAE), version 5, was used to grade AEs and SAEs. Grades 1, 2, 3, and 4 represented mild, moderate, severe, and life-threatening toxicity, respectively. Grade 5 represented toxicity resulting in death. Descriptive analyses were conducted to assess the safety in each grade and summarized as the number of events and rate per subject.
Time frame: through study completion, an average of 18 months
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Procedure technical success
Procedure technical success is determined successfully if all three items are satisfied at the same time during the operation as follow: * Device connected successfully or not; * Microspheres or anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). deliver to target area well, or not by device parts; * There was no unplanned release of radiation or leakage of neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s), or not by device parts.
Time frame: immediately after the procedure