In Which Tumor Burden Range Does Advanced Hepatocellular Carcinoma Patients Benefit More from Hepatic Arterial Infusion Chemotherapy Plus Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors Than Immune Checkpoint Inhibitors Plus Tyrosine Kinase Inhibitors? a Multi-center, Retrospective, Propensity Score Matching Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 97
- 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 different 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 —（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 not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- •Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval;
- •HAIC was performed after the first TKIs/ ICIs treatment or before treatment;
- •Received at least 2 cycles of HAIC or ICIs treatments；
- •Has repeated measurable intrahepatic lesions;
- •Child-Pugh class A or B.
排除标准
- •Patients who took systemic anti-tumor treatments before the combination therapy;
- •With other malignant tumors;
- •Unable to meet criteria of combination timeframe described above.
研究组 & 干预措施
HAIC plus TKIs and ICIs
Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks.
干预措施: hepatic artery infusion chemotherapy (Procedure)
HAIC plus TKIs and ICIs
Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks.
干预措施: Tyrosine kinase inhibitor (TKIs) (Drug)
HAIC plus TKIs and ICIs
Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks.
干预措施: Immune Checkpoint Inhibitors (Drug)
TKIs plus ICIs
Each patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks.
干预措施: Tyrosine kinase inhibitor (TKIs) (Drug)
TKIs plus ICIs
Each patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks.
干预措施: Immune Checkpoint Inhibitors (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)(Up to approximately 2 years)
- Objective response rate(ORR) per RESCIST 1.1(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