MANDARIN (S6371)

A Multicentre, Prospective, Open-label, Randomized Controlled Trial on the Efficacy and Safety of TheraSphereTM (Yttrium-90 Glass Microspheres) Compared to Conventional Transarterial Chemoembolization (cTACE) in Chinese Patients With Inoperable Hepatocellular Carcinoma

To evaluate the efficacy and safety of TheraSphereTM yttrium [90Y] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.

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