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

NCT05016245•Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

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
+10 more criteria

Locations (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Key Dates

Start Date

September 13, 2021

Primary Completion Date

February 13, 2026

Completion Date

October 30, 2026

Last Updated

March 5, 2026

Enrollment

ACTUAL participants

Conditions

Inoperable Hepatocellular Carcinoma

Interventions

TheraSphere™ Yttrium-90 Glass Microspheres

COMBINATION_PRODUCT

conventional Transarterial Chemoembolization(cTACE)

PROCEDURE