TACE-HAIC Combined With Targeted Therapy and Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Propensity Score Matching Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 743
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
Hepatocellular carcinoma (HCC) is characterized with vascular invasion, particularly of the portal vein, resulting in portal vein tumor thrombus (PVTT) in 10%-40% of HCC patients at the time of HCC diagnosis. The prognosis of these patients is extremely poor.Treatment efficacy and safety using a combined therapy (TACE-HAIC combined with TKIs and PD-1 inhibitors) were compared with TACE alone in treatment of HCC patients with 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
- •(a) HCC patients with PVTT (Vp1-4) treated by TACE, or the combination therapy (TACE-HAIC combined with TKIs or an PD-1 inhibitors) as initial treatment; (b) age between 18 and 75 years; (c) Child-Pugh A or B liver function; (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1; (e) adequate hematologic blood counts (white blood cell count >3ⅹ109/L, absolute neutrophil count >1.5ⅹ109/L, platelet count >10ⅹ109/L, hemoglobin concentration >85 g/L); (f) no extrahepatic metastasis.
排除标准
- •(a) severe underlying cardiac, pulmonary, or renal diseases; (b) history of a second primary malignant tumor; (c) incomplete medical data; (d) loss to follow-up.
研究组 & 干预措施
Combined therapy group (TACE-HAIC combined with TKIs and PD-1 inhibitors)
Patients recieve combined with TKIs and PD-1 inhibitors
干预措施: TACE-HAIC (Procedure)
Combined therapy group (TACE-HAIC combined with TKIs and PD-1 inhibitors)
Patients recieve combined with TKIs and PD-1 inhibitors
干预措施: Targeted therapy (Drug)
Combined therapy group (TACE-HAIC combined with TKIs and PD-1 inhibitors)
Patients recieve combined with TKIs and PD-1 inhibitors
干预措施: PD-1 inhibitors (Drug)
TACE alone group
TACE alone
干预措施: TACE (Procedure)
结局指标
主要结局
Tumor Response
时间窗: 24 months
The tumor responses were evaluated by measuring the longest diameter of target lesions according to response evaluation criteria in solid tumors (RECIST) version 1.1
Overall survival
时间窗: 24 months
Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
Progression-free survival
时间窗: 24 months
Progression-free survival (PFS) was measured from the initiation of transarterial therapy to the time of progression or recurrence or last follow-up.
次要结局
- Conversion rate(24 rates)
研究者
Yunfei Yuan
Professor
Sun Yat-sen University