Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: 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
- 22
- 试验地点
- 1
- 主要终点
- Rates of technical success
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. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.
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. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. However, the PVTT induced portal hypertension still needs clinical evidence. In this study, the investigators explore the early TIPS for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. The investigators aim to added 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
盲法说明
TIPS was performed within 72 hours after variceal bleeding.
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;
- •TIPS was performed within 72 hours after the endoscopic hemostasis;
- •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.
结局指标
主要结局
Rates of technical success
时间窗: 3 months
Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS.
次要结局
- Rates of gastrointestinal hemorrhage(6 months)
- Progression-Free-Survival (PFS)(12 months)
- Overall survival (OS)(12 months)
- Objective response rate (ORR)(12 months)
- Adverse events(12 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University