MANDARIN (S6371)
- Conditions
- Inoperable Hepatocellular Carcinoma
- Interventions
- Procedure: conventional Transarterial Chemoembolization(cTACE)Combination Product: TheraSphere™ Yttrium-90 Glass Microspheres
- Registration Number
- NCT05016245
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
To evaluate the efficacy and safety of TheraSphereTM yttrium \[90Y\] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 92
- ≥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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional Transarterial Chemoembolization(cTACE) conventional Transarterial Chemoembolization(cTACE) - TheraSphere™ Yttrium-90 Glass Microspheres TheraSphere™ Yttrium-90 Glass Microspheres -
- Primary Outcome Measures
Name Time Method Time to progression (TTP) through study completion, an average of 18 months Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0 within 60 days post treatment Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
- Secondary Outcome Measures
Name Time Method 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 Safety assess: to standardize reporting, the National Cancer Institute Common Terminology Criteria (NCI CTCAE), version 5, was used to grade AEs and SAEs. Grades 1, 2, 3, and 4 represented mild, moderate, severe, and life-threatening toxicity, respectively. Grade 5 represented toxicity resulting in death. Descriptive analyses were conducted to assess the safety in each grade and summarized as the number of events and rate per subject.
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 Procedure technical success immediately after the procedure Procedure technical success is determined successfully if all three items are satisfied at the same time during the operation as follow:
* Device connected successfully or not;
* Microspheres or anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). deliver to target area well, or not by device parts;
* There was no unplanned release of radiation or leakage of neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s), or not by device parts.
Trial Locations
- Locations (1)
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China