MANDARIN (S6371)

Last updated: May 21, 2026
Sponsor: Boston Scientific Corporation
Overall Status: Active - Not Recruiting

Phase

3

Condition

Carcinoma

Treatment

conventional Transarterial Chemoembolization(cTACE)

TheraSphere™ Yttrium-90 Glass Microspheres

Clinical Study ID

NCT05016245
S6371
  • Ages 18-80
  • All Genders

Study Summary

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

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

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: conventional Transarterial Chemoembolization(cTACE)
Phase: 3
Study Start date:
September 13, 2021
Estimated Completion Date:
October 30, 2026

Connect with a study center

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing 1799962, Jiangsu 1806260 210009
    China

    Site Not Available

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