Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without Transarterial Chemoembolization as First-line Treatment for Advanced Hepatocellular Carcinoma With Vascular Invasions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,651
- 试验地点
- 1
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma with vascular invasions
详细描述
The vascular invasions is a common complication in 16% to 30% of patients with hepatocellular carcinoma (HCC), contributing to poor prognosis and increasing the risk of cancer recurrence, with a median survival of approximately 2.7 to 4 months without intervention. Both the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases guidelines recommend that HCC patients with vascular invasions be classified as Barcelona Clinic Liver Cancer Stage C and receive systemic treatments. Nevertheless, there is limited data on patients with highly complicated HCC and no optimal treatment strategy for this patient population. anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors and immune checkpoint inhibitors (ICIs) are commonly utilized in the systemic therapy of HCC, while the combination of transcatheter arterial chemoembolization (TACE) with systemic therapy has significantly improved treatment outcomes in advanced-stage patients. Therefore, we hypothesized that a triplet regimen comprising TACE,anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors, and ICIs may yield better prognoses for HCC patients with vascular invasions. This study aims to compare the safety and efficacy of the triplet regimen of anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors, ICIs, and TACE versus Lenvatinib combined with ICIs in advanced-stage HCC with vascular invasions
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- •Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of macrovascular invasion;
- •Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- •Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- •TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
- •Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
- •Has repeated measurable intrahepatic lesions;
排除标准
- •Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- •Unable to meet criteria of combination timeframe described above;
- •Child-Pugh C or PS>2 or Severe hepatic encephalopathy
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.
Progression free survival(PFS) according to per mRECIST or RECIST 1.1
时间窗: up to approximately 2 years
per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Description: The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first. PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Description: The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
次要结局
- ORR per mRECIST(up to approximately 2 years)
- Objective response rate(ORR) per RESCIST 1.1(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
Gao-jun Teng
President
Zhongda Hospital