Yttrium-90 Selective Internal Radiation Therapy (SIRT) Combined With Lenvatinib and PD-(L)1 Inhibitors Versus Transarterial Chemoembolization (TACE) Combined With Lenvatinib and PD-(L)1 Inhibitors for Intermediate-Advanced Hepatocellular Carcinoma: A Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This multicenter retrospective study evaluated the efficacy and safety of selective internal radiation therapy (SIRT) combined with lenvatinib and PD-(L)1 inhibitors (SIRT-L-P) versus transarterial chemoembolization (TACE) combined with lenvatinib and PD-(L)1 inhibitors (TACE-L-P) in patients with HCC beyond up-to-seven criteria or with portal vein tumor thrombus (PVTT). Tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were compared between the two groups.
详细描述
Consecutive patients with HCC beyond up-to-seven criteria or with PVTT treated with SIRT-L-P or TACE-L-P from June 2022 to October 2024 were screened. Tumor response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Clinical outcomes, including tumor response, PFS, OS, and AEs were compared between the two groups.
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
- •histologically or clinically confirmed diagnosis of HCC at BCLC stage B or C (extrahepatic metastases were allowed)
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
- •Child-Pugh class A or B7
- •unresectable HCC with intrahepatic tumor beyond up-to-seven criteria and/or with PVTT.
排除标准
- •receipt of other loco-regional therapies, including hepatic arterial infusion chemotherapy, external radiation therapy, or radioactive seed implantation
- •Prior systemic therapy
- •History of other malignancies
- •incomplete medical records
结局指标
主要结局
Progression-free survival
时间窗: 32 months
The time from the first SIRT or TACE procedure until the date that progressive disease according to mRECIST or death was confirmed.
次要结局
- Objective response rate (ORR)(32 months)
- Overall survival(32 months)
- Disease control rate (DCR)(32 months)