To evaluate the efficacy and safety of TheraSphereTM yttrium \[90Y\] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 …
What they're measuring
1
Time to progression (TTP)
Timeframe: through study completion, an average of 18 months
2
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0