MANDARIN (S6371)
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
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Inoperable Hepatocellular Carcinoma
Age
18 - 80
Phase
PHASE3
Participants Needed
90
Est. Completion Date
Oct 30, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Boston Scientific Corporation
ClinicalTrials.gov NCT Identifier
NCT05016245
Study Number
S6371
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?