MANDARIN (S6371)

NCT05016245 | Active Not Recruiting Phase 3 FDA Device

• 1 other identifier: S6371
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inoperable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Time to progression (TTP)

  Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST

  through study completion, an average of 18 months

• Safety assessed within 60 days post treatment using NCI-CTCAE v5.0

  Safety assessed within 60 days post treatment using NCI-CTCAE v5.0

  within 60 days post treatment

Secondary Outcomes (6)

• Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area)

  through study completion, an average of 18 months

• Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area)

  through study completion, an average of 18 months

• Confirmed ORR according to mRECIST

  through study completion, an average of 18 months

• OS (Overall Survival)

  through study completion, an average of 18 months

• Safety assessed using NCI-CTCAE v 5.0

  through study completion, an average of 18 months

Study Arms (2)

TheraSphere™ Yttrium-90 Glass Microspheres

EXPERIMENTAL

Combination Product: TheraSphere™ Yttrium-90 Glass Microspheres

conventional Transarterial Chemoembolization(cTACE)

ACTIVE COMPARATOR

Procedure: conventional Transarterial Chemoembolization(cTACE)

Interventions

TheraSphere™ Yttrium-90 Glass Microspheres COMBINATION_PRODUCT

TheraSphere™ Yttrium-90 Glass Microspheres TheraSphere™ is steam sterilized and supplied in 6 standard dose sizes: 3 GBq, 5 GBq, 7 GBq, 10 GBq, 15 GBq, 20 GBq. Custom dose sizes are also available in 0.5 GBq increments between 3 and 20 GBq. TheraSphereTM is supplied with the following accessories: Administration Set Administration Accessory Kit

TheraSphere™ Yttrium-90 Glass Microspheres

conventional Transarterial Chemoembolization(cTACE) PROCEDURE

conventional Transarterial Chemoembolization(cTACE) is comprised of an anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). The choice of agent(s) to be used is per usual local site practice. Chemotherapy agents can be as a single agent or used in combination, as per local practice.

conventional Transarterial Chemoembolization(cTACE)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

Study Officials

• Gaojun TENG, Dr.

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 23, 2021
• Study Start: September 13, 2021
• Primary Completion: February 13, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)