NCT04961918Unknown2 期
The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年7月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
To evaluate the efficacy of HAIC combine Lenvatinib and Durvalumab (HILL) in advanced HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; cannot accepted hepatectomy; 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 HAIC or lenvatinib or durvalumab; 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;
结局指标
主要结局
PFS
时间窗: From date of randomization until the date of progression, assessed up to 36 months
progression-free survival
次要结局
- ORR(From date of randomization until the date of death, assessed up to 36 months)
- DCR(From date of randomization until the date of death, assessed up to 36 months)
- OS(From date of randomization until the date of death from any cause, assessed up to 36 months)
研究者
Rong-ping Guo
Professor
Sun Yat-sen University
研究点 (1)
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