TACE Combined With Lenvatinib and PD-1 Inhibitor for Spontaneous Rupture of Hepatocellular Carcinoma: a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Progression-Free-Survival (PFS)
研究概览
简要总结
Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.
详细描述
Spontaneous rupture of HCC is a life-threatening complication. HCC rupture is considerably higher in China. The tumor size in ruptured HCC is significantly greater than that in non-ruptured HCC. In the acute phase, hemostasis is the first concern and then tumor treatment is secondary. TACE can effectively induce hemostasis. Conservative treatment is usually system therapy for unresectable ruptured HCC. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of TACE combined lenvatinib and PD-1 inhibitor for unresectable ruptured HCC. This study focuses on the efficacy of TACE combined with lenvatinib and PD-1 inhibitor as first-line therapy.
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 hemostasis in the enhanced CT scan;
- •integrity of the tumor is disrupted and there is hematoma around the liver;
- •receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
- •transarterial artery chemoembolization (TACE) as local 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.
- •life expectancy more than 3 months;
- •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;
- •non-ruptured HCC;
- •Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
- •age < 18 years or > 75 years;
- •HCC with more than five metastases;
- •History of hepatic encephalopathy and gastrointestinal bleeding
- •life expectancy less than 3 months.
研究组 & 干预措施
TACE plus Lenvatinib and PD-1 inhibitor
TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.
干预措施: TACE (Procedure)
TACE plus Lenvatinib and PD-1 inhibitor
TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.
干预措施: Lenvatinib (Drug)
TACE plus Lenvatinib and PD-1 inhibitor
TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.
干预措施: PD-1 Inhibitors (Drug)
结局指标
主要结局
Progression-Free-Survival (PFS)
时间窗: 12 months
Progression was defined as progressive disease by independent radiologic review
次要结局
- Objective response rate (ORR)(12 months)
- Overall survival (OS)(12 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University