A Single-center Randomized Controlled Clinical Trial of TACE Combined With Anlotinib Comparing With TACE in the Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study was designed to evaluate the effectiveness of Anlotinib in middle-advanced Hepatocellular Carcinoma (HCC) Patients.
详细描述
The aim of this study is to include 40 patients with middle-advanced Hepatocellular Carcinoma .These patients were randomly allocated to TACE treatment group or TACE+Anlotinib treatment group.The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.
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
- •Subject has no contraindication to chemotherapy, and has no obvious obstacles in the function of major organs such as heart, lung, liver and kidney;
- •Subject has middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C ;
- •Liver function child-pugh class A or B; Karnofsky (KPS) score > 60 points;
- •Subject could not accept surgical resection or refuse surgical operation;and who did not receive other treatment before operation.
- •5.18~75 years old; ECOG PS score: 0-1 points; expected survival period is more than 3 months.
排除标准
- •Subject has contraindications to chemotherapy;
- •Subject has obstacle in the function of major organs such as heart, lung, liver and kidney;
- •Severe coagulation dysfunction (prothrombin time > 18 s or hemorrhagic tendency);
- •Uncontrollable hypertension and portal hypertension;
- •Hepatic artery-portal vein or hepatic vein fistula or portal vein trunk cancer thrombus;
- •A large amount of ascites or refractory ascites;
- •With distant metastasis.
研究组 & 干预措施
TACE group
Device: Transcatheter arterial chemoembolization(TACE)
干预措施: TACE (Device)
TACE+Anlotinib group
Device: Transcatheter arterial chemoembolization Drug: Anlotinib Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.
干预措施: TACE (Device)
TACE+Anlotinib group
Device: Transcatheter arterial chemoembolization Drug: Anlotinib Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.
干预措施: Anlotinib Hydrochloride (Drug)
结局指标
主要结局
PFS
时间窗: 12 months
Progress Free Survival
次要结局
未报告次要终点