Study on the Safety and Effectiveness of Transcatheter Arterial Chemoembolization (TACE) Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With Microvascular Invasion (MVI) Positive Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recurrence-free survival (RFS) evaluation
研究概览
简要总结
single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of microvascular invasion (MVI) positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.
详细描述
Focusing on the current status of clinical treatment of microvascular invasion (MVI) positive postoperative hepatocellular carcinoma (HCC) , single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of MVI-positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Radical hepatocellular carcinoma was treated 4 weeks (±1 week) ago, and the pathological diagnosis was HCC after surgery, and MVI was positive
- •Child-Pugh score ≤9 points (Child-Pugh A-B), PS score 0-2 points, BCLC stage A-B
- •The main portal vein is not completely obstructed, or although it is completely obstructed, the compensatory collateral branches of the portal vein are abundant or the portal vein blood flow can be restored by implanting the portal vein stent
- •With sufficient organ and bone marrow function, the laboratory test values within 7 days before enrollment meet the requirements
- •Physical fitness score ECOG 0～2
- •Expected survival> 3 months
- •No other systemic malignancies
- •Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period
- •Subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents
排除标准
- •Histology includes fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
- •Severe liver dysfunction (Child-Pugh C), including jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome, or a history of liver transplantation
- •The main portal vein is completely blocked, and the formation of collateral vessels is small
研究组 & 干预措施
Intervention group
patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.
干预措施: Lenvatinib (Drug)
control group
patients receive transcatheter arterial chemoembolization (TACE) only.
干预措施: TACE (Procedure)
Intervention group
patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.
干预措施: TACE (Procedure)
结局指标
主要结局
Recurrence-free survival (RFS) evaluation
时间窗: Through study completion, an average of 1 year
To evaluate the recurrence-free survival of patients with MVI-positive HCC after TACE combined with lenvatinib treatment
Incidence of adverse events
时间窗: Up to 8 weeks
To evaluate the safety of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
Changes in tumor volume
时间窗: Up to 8 weeks
To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
次要结局
- Overall survival ( OS) evaluation(Through study completion, an average of 1 year)
- Disease recurrence time evaluation(Through study completion, an average of 1 year)