Transjugular Intrahepatic Portosystemic Shunt Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus: a Multicenter Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Rates of gastrointestinal hemorrhage
研究概览
简要总结
Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.
详细描述
Portal hypertension by main trunk portal vein tumor thrombus (PVTT) is a severe disease. Patients usually die of gastrointestinal hemorrhage rather than tumor progression. It is vital to prevent the portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method to alleviate the portal pressure. Then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. In this study, the investigators explore the TIPS combined with Lenvatinib and PD-1 inhibitor for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus. The investigators aim to add clinical evidence for this subtype of advanced HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- •presence of PVTT with III-IV grade by Cheng's criteria;
- •having PVTT induced portal hypertension;
- •with or without PVTT induced acute variceal bleeding;
- •metastases with limited five sites and no more two organs involved;
- •Number of Intrahepatic tumors were no more than five;
- •receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
- •classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
- •no history of other malignancies;
- •agreed to participated in this clinical trial;
- •Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.
排除标准
- •recurrent HCC;
- •PVTT at I-II grade by Cheng's criteria;
- •age < 18 years or > 75 years;
- •advanced HCC with more than five metastases;
- •Number of Intrahepatic tumors were more than five;
- •no response to Lenvatinib;
- •life expectancy less than 3 months.
研究组 & 干预措施
Transjugular intrahepatic portosystemic shunt
A needle punctured the portal vein through the transjugular approach. After a successful puncture, the parenchymal tract was dilated, and covered stents were introduced. The specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8 mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80 mm. The portal vein pressure was measured before and after shunt creation. After the insertion of TIPS, all of the participants received a diuretic treatment and a salt-limited diet.
干预措施: Transjugular intrahepatic portosystemic shunt (Procedure)
Transjugular intrahepatic portosystemic shunt
A needle punctured the portal vein through the transjugular approach. After a successful puncture, the parenchymal tract was dilated, and covered stents were introduced. The specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8 mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80 mm. The portal vein pressure was measured before and after shunt creation. After the insertion of TIPS, all of the participants received a diuretic treatment and a salt-limited diet.
干预措施: Lenvatinib (Drug)
Transjugular intrahepatic portosystemic shunt
A needle punctured the portal vein through the transjugular approach. After a successful puncture, the parenchymal tract was dilated, and covered stents were introduced. The specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8 mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80 mm. The portal vein pressure was measured before and after shunt creation. After the insertion of TIPS, all of the participants received a diuretic treatment and a salt-limited diet.
干预措施: PD-1 inhibitor (Drug)
结局指标
主要结局
Rates of gastrointestinal hemorrhage
时间窗: 6 months
atients occur gastrointestinal hemorrhage within 6 months after TIPS.
次要结局
- Progression-Free-Survival (PFS)(12 months)
- Overall survival (OS)(24 months)
- Objective response rate (ORR)(6 months)
- Adverse events(24 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University