Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- •Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
- •Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
- •Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
- •HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
- •Received at least 2 cycles of HAIC；
- •Has repeated measurable intrahepatic lesions;
- •Child-Pugh class A or B.
排除标准
- •The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
- •With other malignant tumors;
- •Unable to meet criteria of combination timeframe described above.
研究组 & 干预措施
HAIC plus Lenvatinib and PD-1 inhibitors
Each patient should receive at least 2 cycles of HAIC and 1cycles of PD-1 plus Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 weeks.
干预措施: hepatic artery infusion chemotherapy (Procedure)
HAIC plus Lenvatinib and PD-1 inhibitors
Each patient should receive at least 2 cycles of HAIC and 1cycles of PD-1 plus Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 weeks.
干预措施: Lenvatinib + PD-1 monoclonal antibody (Drug)
结局指标
主要结局
Overall survival
时间窗: Up to approximately 2 years
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
次要结局
- Progression free survival(PFS) (Overall)(Up to approximately 2 years)
- Progression free survival(PFS) of intra-hepatic lesions(Up to approximately 2 years)
- Progression free survival(PFS) of extra-hepatic lesions(Up to approximately 2 years)
- Progression free survival(PFS) of portal vein tumor thrombus (PVTT)(Up to approximately 2 years)
- Objective response rate(ORR) per RESCIST 1.1(Up to approximately 2 years)
- ORR per mRECIST(Up to approximately 2 years)
- ORR of PVTT(Up to approximately 2 years)
- Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0(Up to approximately 2 years)
研究者
Haibo Shao
Professor, MD, PhD
First Hospital of China Medical University