NCT05016245已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
To evaluate the efficacy and safety of TheraSphereTM yttrium [90Y] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
TheraSphere™ Yttrium-90 Glass Microspheres
Experimental
干预措施: TheraSphere™ Yttrium-90 Glass Microspheres (Combination Product)
conventional Transarterial Chemoembolization(cTACE)
Active Comparator
干预措施: conventional Transarterial Chemoembolization(cTACE) (Procedure)
结局指标
主要结局
Time to progression (TTP)
时间窗: 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
时间窗: within 60 days post treatment
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
次要结局
- 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)
研究者
研究点 (1)
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