MANDARIN (S6371)
- Conditions
- Inoperable Hepatocellular Carcinoma
- Registration Number
- NCT05016245
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria:<br><br> - =18 and =80 age and provided study consent<br><br> - Patients diagnosed with HCC and clinically evaluated as inoperable (as per local<br> practice) or who refuse operation (ablation, hepatectomy and liver transplantation)<br><br> - At least one well defined HCC tumor measurable by mRECIST in contrast-enhanced MRI<br><br> - China liver cancer staging (CNLC) stage Ib~IIb<br><br> - Child-Pugh = B7<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status = 1<br><br> - Tumor burden =50% of the total liver volume<br><br>Exclusion Criteria:<br><br> - Presence of extra-hepatic metastases or additional malignancies aside from HCC<br><br> - Patients with hepatic artery malformation and unable to intubate hepatic artery<br><br> - Patients who are allergic to contrast agents or have renal insufficiency (Serum<br> creatinine>2mg/ml or Creatinine clearance<30mL/min) and are not suitable for<br> injection of contrast agents<br><br> - Severe pulmonary insufficiency (FEV1/FVC<50% or FEV1/predicting value<50% or<br> MVV<50L/min)<br><br> - AST and ALT >5 times upper limit of normal<br><br> - Clinical manifestations of decompensated cirrhosis (Grade2/3 of ascites,<br> gastrointestinal bleeding, hepatic encephalopathy, etc. according to EASL Clinical<br> Practice Guidelines)<br><br> - HCC invading biliary tract or causing biliary obstruction<br><br> - uncorrectable coagulation dysfunction and severe hemogram abnormality [Prothrombin<br> time (PT)>6 seconds above control or PT-International normalized ratio (INR)>2.5,<br> WBC<3.0x109/L, PLT<50x109/L]<br><br> - Infiltrative HCC tumor type<br><br> - Bilobar HCC disease<br><br> - Any presence of portal vein or hepatic veins or artery invasion<br><br> - Occlusion of portal vein completely with less collateral vessels<br><br> - Transjugular intrahepatic portosystemic shunt (TIPS) or Hepatic arterioportal<br> fistula<br><br> - Patients during pregnancy or lactation<br><br> - Prior interventional therapy via hepatic artery or radiotherapy treatment for HCC<br><br> - Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows<br> any deposition to the gastrointestinal tract that may not be corrected by<br> angiographic techniques<br><br> - Radiation pneumonitis has been seen in patients receiving doses to the lungs greater<br> than 30 Gy in a single treatment or greater than 50Gy in multiple treatment<br><br> - The absorbed dose of lung may exceed 30Gy in preoperative evaluation<br><br> - Receive any investigational therapy or anti-tumor therapy within 30 days prior to<br> study enrollment<br><br> - Any other reason in which the investigator believes that the patient is unsuitable<br> to participate in this trial
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to progression (TTP);Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area);Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area);Confirmed ORR according to mRECIST;OS (Overall Survival);Safety assessed using NCI-CTCAE v 5.0;Procedure technical success