Inoperable Hepatocellular Carcinoma
Conditions
Brief summary
To evaluate the efficacy and safety of TheraSphereTM yttrium \[90Y\] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
Interventions
COMBINATION_PRODUCTTheraSphere™ Yttrium-90 Glass Microspheres
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
PROCEDUREconventional Transarterial Chemoembolization(cTACE)
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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ≥18 and ≤80 age and provided study consent * Patients diagnosed with HCC and clinically evaluated as inoperable (as per local practice) or who refuse operation (ablation, hepatectomy and liver transplantation) * At least one well defined HCC tumor measurable by mRECIST in contrast-enhanced MRI * China liver cancer staging (CNLC) stage Ib\~IIb * Child-Pugh ≤ B7 * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * Tumor burden ≤50% of the total liver volume
Exclusion criteria
* Presence of extra-hepatic metastases or additional malignancies aside from HCC * Patients with hepatic artery malformation and unable to intubate hepatic artery * Patients who are allergic to contrast agents or have renal insufficiency (Serum creatinine\>2mg/ml or Creatinine clearance\<30mL/min) and are not suitable for injection of contrast agents * Severe pulmonary insufficiency (FEV1/FVC\<50% or FEV1/predicting value\<50% or MVV\<50L/min) * AST and ALT \>5 times upper limit of normal * Clinical manifestations of decompensated cirrhosis (Grade2/3 of ascites, gastrointestinal bleeding, hepatic encephalopathy, etc. according to EASL Clinical Practice Guidelines) * HCC invading biliary tract or causing biliary obstruction * uncorrectable coagulation dysfunction and severe hemogram abnormality \[Prothrombin time (PT)\>6 seconds above control or PT-International normalized ratio (INR)\>2.5, WBC\<3.0x109/L, PLT\<50x109/L\] * Infiltrative HCC tumor type * Bilobar HCC disease * Any presence of portal vein or hepatic veins or artery invasion * Occlusion of portal vein completely with less collateral vessels * Transjugular intrahepatic portosystemic shunt (TIPS) or Hepatic arterioportal fistula * Patients during pregnancy or lactation * Prior interventional therapy via hepatic artery or radiotherapy treatment for HCC * Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques * Radiation pneumonitis has been seen in patients receiving doses to the lungs greater than 30 Gy in a single treatment or greater than 50Gy in multiple treatment * The absorbed dose of lung may exceed 30Gy in preoperative evaluation * Receive any investigational therapy or anti-tumor therapy within 30 days prior to study enrollment * Any other reason in which the investigator believes that the patient is unsuitable to participate in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression (TTP) | through study completion, an average of 18 months | Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST |
| Safety assessed within 60 days post treatment using NCI-CTCAE v5.0 | within 60 days post treatment | Safety assessed within 60 days post treatment using NCI-CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area) | through study completion, an average of 18 months | — |
| Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area) | through study completion, an average of 18 months | — |
| Confirmed ORR according to mRECIST | through study completion, an average of 18 months | — |
| OS (Overall Survival) | through study completion, an average of 18 months | — |
| Safety assessed using NCI-CTCAE v 5.0 | through study completion, an average of 18 months | 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. |
| Procedure technical success | immediately after the procedure | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORGaojun TENG, Dr.
Zhongda Hospital
Outcome results
None listed