A Multicenter, Randomized, Positive Parallel Controlled Clinical Trial of PVE/PVL Combined With DEB-TACE in the Treatment of Large or Large Liver Cancer in the Right Lobe of the Liver Without Hepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- FLR
研究概览
简要总结
This is a multicenter, randomized, positive parallel controlled clinical study to evaluate the short-term and long-term efficacy and safety of PVL/PVE combined with DEB-TACE in the treatment of unresectable patients with large or large tumors in the right lobe of the liver.
详细描述
Most guidelines recommend transarterial chemoembolization (TACE) as the standard of treatment for hepatocellular carcinoma（HCC）which is limited to the right half of the liver, single large or multiple, with / without tumor thrombus of the right branch of the portal vein.While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma. Portal vein embolization(PVE)/portal vein ligation(PVL) is the main means to increase the future liver remnant (FLR), which can reduce the complications after hepatectomy. TACE on the basis of PVE/PVL can not only increase FLR, but also can effectively control the progression of tumor by sequential TACE. This study intends to conduct a multicenter, randomized, positive parallel-controlled clinical study to objectively and scientifically evaluate the short-term and long-term efficacy and safety of ligation of the right portal vein combined with Drug-eluting bead transarterial chemoembolization(DEB-TACE) technique in the treatment of patients with large or large tumors of the right lobe who cannot be resected in I-stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Clinically diagnosed as large or giant hepatocellular carcinoma of the right lobe of the liver;
- •Child-Pugh liver function grade A,
- •ECOG PS 0-1
- •If the tumor is resected with R0, the remaining liver volume is insufficient
- •ICG-15R < 30%
- •No serious organic diseases of heart, lung, brain and other organs;
- •No history of other malignant tumors;
- •The patient's survival time is expected to be more than 3 months.
排除标准
- •Pregnant and lactating women
- •History of organ transplant
- •Tumor thrombus with portal vein trunk or left branch involved;
- •distant metastasis;
- •Patients with obvious liver cirrhosis (Plt < 100 × 10 ^ 9 / L at admission or gastroscopy suggested esophageal and gastric varices);
- •Active bleeding caused by various causes;
- •Suffering from severe acute or chronic diseases or infectious diseases;
- •History of hepatectomy or TACE treatment.
结局指标
主要结局
FLR
时间窗: Until one month after the last treatment.
the ratio of FLR proliferation after treatment
the rate of tumor resection after treatment
时间窗: Until one month after the last treatment.
次要结局
- Overall survival (OS)(After operation, up to 3 years)
- Progression-free survival (PFS)(1, 3 year)