An Observational Study to Evaluate the Safety and Efficacy of Lenvatinib in HCC Subjects Who Have Progressive Disease After First Line Treatment With Checkpoint Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Response rate (RR)
研究概览
简要总结
The objective of this study is to evaluate the efficacy of lenvatinib in HCC subjects who have progressive disease after first line treatment with checkpoint inhibitors.
Approximately 20 subjects will be enrollment to evaluate the efficacy and safety of lenvatinib.
CT/MRI assessments will be made at end of first line treatment with checkpoint inhibitors, and every 8-12 weeks thereafter. Disease status will be determined at the site (ie. Investigator and/or radiologist) using RECIST version 1.1.
The primary efficacy endpoint is response rate (RR) defined as proportion of subjects with SD/PR/CR per RECIST 1.1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old on the day of consent
- •Capable of understanding and complying with the protocol requirements and signed informed consent
- •Documented histological or cytological diagnosis of HCC
- •HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1
排除标准
- •Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
- •Prior TKI treatment
研究组 & 干预措施
Lenvatinib
Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib.
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Response rate (RR)
时间窗: 12 month
It is the sum of the proportion of stable disease (SD), complete response (CR) and partial response(PR) per RECIST 1.1. That is, RR = SD + CR + PR
次要结局
- Adverse Events(12 month)