Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.
详细描述
This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.
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
- •primary infiltrative HCC according to MRI or CT imaging characteristics.
- •Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
- •Lenvatinib as initial treatment.
- •patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.
- •no history of other malignancies.
- •no tumor thrombus in the atrium or vena cava.
排除标准
- •HCC with tumor capsule.
- •under 18 years or over 75 years.
- •TACE as initial treatment.
- •sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.
- •incomplete tumor imaging data.
- •lost to follow-up after treatment within three months.
研究组 & 干预措施
HAIC+Len+PD-1 inhibitor group
HAIC combined with Lenatinib and PD-1 inhibitor group
干预措施: Camrelizumab (Drug)
HAIC+Len+PD-1 inhibitor group
HAIC combined with Lenatinib and PD-1 inhibitor group
干预措施: Hepatic arterial infusion chemotherapy (Procedure)
HAIC+Len+PD-1 inhibitor group
HAIC combined with Lenatinib and PD-1 inhibitor group
干预措施: Lenvatinib (Drug)
HAIC+Len+PD-1 inhibitor group
HAIC combined with Lenatinib and PD-1 inhibitor group
干预措施: Tislelizumab (Drug)
HAIC+Len+PD-1 inhibitor group
HAIC combined with Lenatinib and PD-1 inhibitor group
干预措施: Toripalimab (Drug)
HAIC+Len+PD-1 inhibitor group
HAIC combined with Lenatinib and PD-1 inhibitor group
干预措施: Sintilimab (Drug)
Len group
Lenvatinib alone
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Overall survival
时间窗: 24 months
OS is the length of time from the date of inclusion until death from any cause.
次要结局
- Progression-Free-Survival(12 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University