MANDARIN (S6371)

Boston Scientific

Status and phase

Active, not recruiting

Phase 3

Conditions

Inoperable Hepatocellular Carcinoma

Treatments

Procedure: conventional Transarterial Chemoembolization(cTACE)

Combination Product: TheraSphere™ Yttrium-90 Glass Microspheres

Study type

Interventional

Funder types

Industry

Identifiers

NCT05016245

S6371

Details and patient eligibility

About

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

Enrollment

92 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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