Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Tumor-free survival rate at 36 months
研究概览
简要总结
This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC
详细描述
Microwave ablation (MWA) is available as the major curative treatments for early-stage recurrent HCC. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated MWA simultaneously combined Lenvatinib for recurrent HCC. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this randomized, multicenter, prospective trial study to find out it.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary HCC (BCLC 0-B), and the pathological results is hepatocellular carcinoma；
- •recurrent HCC without any tumor related therapy；
- •Tumor number ≤3；
- •Tumor size ≤5cm;
- •Good performance, KPS≥90；
- •Child-Pugh A or B（score of the B level is no more than 7）
- •Baseline laboratory examinations meet the Criteria： Leukocyte ≥3.0×109/L； Blood platelet ≥75×109/L； Hemoglobin ≥100g/L； ALT、AST ≤ 3 x limit of normal（ULN）； Serum creatinine ≤ 1.5 x ULN； Prothrombin time < ULN+4 s；INR < 1.5, Albumin ≥30g/L ； Total bilirubin ≤34mmol/L；
排除标准
- •disagreeing to receive follow-up observation and participate the clinical study;
- •Accompanying with a history of other malignancies;
- •Accompanying with macrovascular invasion such as portal vain tumor thrombus, hepatic vein tumor thrombus;
- •with extrahepatic metastasis or lymph metastasis;
- •receiving system therapy such as targeted therapy or immunotherapy;
- •receiving local therapy such as ablation or TACE;
- •Any of the following occurred within 12 months of the study: myocardial infarction, severe / unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; ongoing arrhythmia by NCI-CTCA standard ≥ 2, prolonged QTc interval (450 ms for males, and> 470 ms for females;
- •other serious acute, chronic physiological or mental disorders or abnormal laboratory examination may increase the risk of participation in study treatment or may interfere with the interpretation of study findings or whom the investigator considers not fit;
研究组 & 干预措施
Microwave ablation
Patients only accepted microwave ablation
干预措施: Microwave ablation (Procedure)
Microwave ablation plus lenvatinib
Patients accepted microwave ablation plus lenvatinib
干预措施: Microwave ablation (Procedure)
Microwave ablation plus lenvatinib
Patients accepted microwave ablation plus lenvatinib
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Tumor-free survival rate at 36 months
时间窗: 36 months
Progression was defined as progressive disease after microwave ablation by independent radiologic review according to mRECIST or death from any cause
Over-all survival (OS) rate at 36 months
时间窗: 36 months
OS is the length of time from the date of microwave ablation until death from any cause.
次要结局
- Complication rate(36 months)
- Adverse events(24 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University