NCT04053985Unknown3 期
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2018年1月1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
- 206
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent
排除标准
- •cannot tolerate TAI or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy
研究组 & 干预措施
TAI+lenvatinib group
Experimental
TAI combine lenvatinib
干预措施: TAI combine lenvatinib (Combination Product)
lenvatinib group
Active Comparator
lenvatinib only
干预措施: Lenvatinib (Drug)
结局指标
主要结局
OS
时间窗: From date of randomization until the date of death from any cause, assessed up to 60 months
overall survival
PFS
时间窗: From date of randomization until the date of progress from any cause, assessed up to 60 months
progression-free survival
次要结局
- ORR(From date of randomization until the date of death from any cause, assessed up to 60 months)
- DCR(From date of randomization until the date of death from any cause, assessed up to 60 months)
研究者
Rong-ping Guo
Professor
Sun Yat-sen University
研究点 (1)
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