Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Large Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: a Multicenter Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
This multicenter retrospective study evaluated consecutive patients with large HCC and PVTT who received lenvatinib plus DEB-TACE with/without FOLFOX-HAIC between July 2019 and June 2021. Tumor response, time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups.
详细描述
Consecutive patients with large HCC and PVTT treated with lenvatinib plus drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil and leucovorin (Len+DEB-TACE+HAIC) or lenvatinib plus DEB-TACE (Len+DEB-TACE) from July 2019 to June 2021 were screened. Tumor response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Clinical outcomes, including tumor response, TTP, OS, and TRAEs 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
- •a confirmed diagnosis of HCC
- •the largest intrahepatic lesion >7 cm
- •presence of major PVTT on imaging
- •Eastern Cooperative Oncology Group performance status ≤1
- •Child-Pugh class A/B
- •adequate hematologic and organ function, with leukocyte count 3.0 109/L, neutrophil count 1.5 109/L, platelet count 75 109/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase 5 upper limit of the normal, creatinine clearance rate 1.5 upper limit of the normal, and prothrombin time prolongation <4 s
排除标准
- •incomplete medical records
- •central nervous system involvement
- •previous treatment with transarterial embolization, TACE, HAIC, radiotherapy, or systemic therapy
- •history of malignancies other than HCC
- •history of organ transplantation
- •severe cardiac, pulmonary or renal dysfunction
结局指标
主要结局
Time to progression (TTP)
时间窗: 3.5 years
defined as the time from treatment initiation to the first occurrence of disease progression.
次要结局
- treatment-related adverse events (TRAEs)(3.5 years)
- overall survival(3.5 years)
- objective response rate (ORR)(3.5 years)
- Disease control rate (DCR)(3.5 years)