Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and PD-1 Inhibitors Versus Lenvatinib Plus PD-1 Inhibitors as First-line Treatment for High Tumor Burden Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Target Trial Emulation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
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 high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years old;
- •Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline;
- •At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
- •HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
- •Presence of PVTT;
- •Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib.
- •Child-Pugh class A or B7;
- •Tumor burden meets up to 7 out criteria.
排除标准
- •Patients who took anti-tumor treatments before the combination therapy;
- •With other malignant tumors;
- •incomplete data.
研究组 & 干预措施
HAIC plus Lenvatinib and PD-1 inhibitors
Each patient should receive at least 2 cycles of HAIC, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months.
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, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months.
干预措施: Lenvatinib + PD-1 monoclonal antibody (Drug)
Lenvatinib plus PD-1 inhibitors
Each patient should receive at least 2 cycles of PD-1 inhibitors and 2 months of Lenvatinib.
干预措施: Lenvatinib + PD-1 monoclonal antibody (Drug)
结局指标
主要结局
Overall survival (OS)
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