NCT03905967Unknown3 期
Transarterial Chemoembolization With Lenvatinib Versus Lenvatinib Alone in First-line Treatment of Advanced Hepatocellular Carcinoma: a Phase III, Multicenter, Randomized Controlled Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2019年6月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This trial is is an open label, multicenter, randomized controlled phase 3 clinical trial. The purpose is to compare the efficacy and safety of lenvatinib plus TACE with lenvatinib alone for advanced HCC patients.
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
- •Age 18-75 years old;
- •Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment;
- •There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus or with extrahepatic metastasis;
- •ECOG score 0-1;
- •Child-Pugh class A;
- •Expected survival time ≥ 3 months;
- •Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal
排除标准
- •Preoperative imaging examination revealed diffuse intrahepatic lesions or invasion, inferior vena cava or primary branch bile duct;
- •Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices;
- •There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis;
- •Brain metastases;
- •Hypersensitivity to intravenous contrast agents;
- •Pregnant or lactating women or subjects with family planning within two years;
- •With HIV, syphilis infection;
- •Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment;
- •Allogeneic organ transplant recipients;
- •Severe dysfunction of heart and kidney or other organs;
- •Active severe infection > grade 2 (NCI-CTC version 4);
- •Suffering from mental and psychological diseases may affect informed consent;
- •Unable to take oral medication;
- •Participated in other drug clinical trials within 12 months before enrollment;
研究组 & 干预措施
Lenvatinib + TACE
Experimental
Patients in Lenvatinib + TACE group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib.
干预措施: TACE (Procedure)
Lenvatinib + TACE
Experimental
Patients in Lenvatinib + TACE group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib.
干预措施: Lenvatinib (Drug)
Lenvatinib
Active Comparator
Lenvatinib alone
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Overall survival
时间窗: two years
Defined as the time from randomization to death for any cause.
次要结局
- Time to progression(two years)
研究者
Ming Kuang
Clinical Professor
Sun Yat-sen University
研究点 (1)
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