For Healthcare Professionals



About the study

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

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. ≥18 and ≤80 age and provided study consent
  2. Patients diagnosed with HCC and clinically evaluated as inoperable (as per local practice) or who refuse operation (ablation, hepatectomy and liver transplantation)
  3. At least one well defined HCC tumor measurable by mRECIST in contrast-enhanced MRI
  4. China liver cancer staging (CNLC) stage Ib~IIb
  5. Child-Pugh ≤ B7
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  7. Tumor burden ≤50% of the total liver volume


Exclusion Criteria:

  1. Presence of extra-hepatic metastases or additional malignancies aside from HCC
  2. Patients with hepatic artery malformation and unable to intubate hepatic artery
  3. 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
  4. Severe pulmonary insufficiency (FEV1/FVC<50% or FEV1/predicting value<50% or MVV<50L/min)
  5. AST and ALT >5 times upper limit of normal
  6. Clinical manifestations of decompensated cirrhosis (Grade2/3 of ascites, gastrointestinal bleeding, hepatic encephalopathy, etc. according to EASL Clinical Practice Guidelines)
  7. HCC invading biliary tract or causing biliary obstruction
  8. 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]
  9. Infiltrative HCC tumor type
  10. Bilobar HCC disease
  11. Any presence of portal vein or hepatic veins or artery invasion
  12. Occlusion of portal vein completely with less collateral vessels
  13. Transjugular intrahepatic portosystemic shunt (TIPS) or Hepatic arterioportal fistula
  14. Patients during pregnancy or lactation
  15. Prior interventional therapy via hepatic artery or radiotherapy treatment for HCC
  16. Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques
  17. 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
  18. The absorbed dose of lung may exceed 30Gy in preoperative evaluation
  19. Receive any investigational therapy or anti-tumor therapy within 30 days prior to study enrollment
  20. Any other reason in which the investigator believes that the patient is unsuitable to participate in this trial
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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Inoperable Hepatocellular Carcinoma

Age (in years)

18 - 80


Phase 3

Participants needed


Est. Completion Date

Oct 30, 2026

Treatment type



Boston Scientific Corporation identifier


Study number


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