Phase
Condition
Carcinoma
Treatment
conventional Transarterial Chemoembolization(cTACE)
TheraSphere™ Yttrium-90 Glass Microspheres
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥18 and ≤80 age and provided study consent
Patients diagnosed with HCC and clinically evaluated as inoperable (as per localpractice) 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
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 (Serumcreatinine>2mg/ml or Creatinine clearance<30mL/min) and are not suitable forinjection of contrast agents
Severe pulmonary insufficiency (FEV1/FVC<50% or FEV1/predicting value<50% orMVV<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 ClinicalPractice Guidelines)
HCC invading biliary tract or causing biliary obstruction
uncorrectable coagulation dysfunction and severe hemogram abnormality [Prothrombintime (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 arterioportalfistula
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 showsany deposition to the gastrointestinal tract that may not be corrected byangiographic techniques
Radiation pneumonitis has been seen in patients receiving doses to the lungs greaterthan 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 tostudy enrollment
Any other reason in which the investigator believes that the patient is unsuitableto participate in this trial
Study Design
Connect with a study center
Zhongda Hospital Southeast University
Nanjing, Jiangsu 210009
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing 1799962, Jiangsu 1806260 210009
ChinaSite Not Available

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