Clinical trial · Interventional
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
NCT05016245CI-TRIAL-00121794completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of TheraSphereTM yttrium \[90Y\] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inoperable Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional Transarterial Chemoembolization(cTACE) | Procedure | — | UNRESOLVED |
| TheraSphere™ Yttrium-90 Glass Microspheres | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TheraSphere™ Yttrium-90 Glass Microspheres
- interventionNames
- Combination Product: TheraSphere™ Yttrium-90 Glass Microspheres
- type
- ACTIVE_COMPARATOR
- label
- conventional Transarterial Chemoembolization(cTACE)
- interventionNames
- Procedure: conventional Transarterial Chemoembolization(cTACE)
Primary outcomes (2)
- measure
- Time to progression (TTP)
- timeFrame
- through study completion, an average of 18 months
- description
- Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.