NCT05016245CompletedPhase 3
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
Boston Scientific Corporation1 site in 1 country92 target enrollmentStarted: September 13, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Time to progression (TTP)
Study Overview
Brief Summary
To evaluate the efficacy and safety of TheraSphereTM yttrium [90Y] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TheraSphere™ Yttrium-90 Glass Microspheres
Experimental
Intervention: TheraSphere™ Yttrium-90 Glass Microspheres (Combination Product)
conventional Transarterial Chemoembolization(cTACE)
Active Comparator
Intervention: conventional Transarterial Chemoembolization(cTACE) (Procedure)
Outcomes
Primary Outcomes
Time to progression (TTP)
Time Frame: 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
Time Frame: within 60 days post treatment
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
Secondary Outcomes
- 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)
- 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)
Investigators
Study Sites (1)
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