Transarterial Chemoembolization Versus Transarterial Chemoembolization With Hepatic Artery Chemotherapy Infusion for Patients With Potentially Resectable HCC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to large tumors, surgical treatment is suitable for early-stage and well-reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of potentially resectable HCC.
EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for HCC patients. Several clinical studies showed that HAIC bring better tumor response rate that the conditional TACE. The combination of TACE with HAIC (TACE-HAIC), theoretically can significantly increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC and TACE-HAIC for those patients.
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
- •Age 18-75 years
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- •Diagnosed as potentially resectable with consensus by the panel of liver surgeons
- •stage BCLC A/B, without extra-hepatic involvement
- •No previous anti-HCC treatment
- •Eastern Co-operative Group performance status 2 or less
- •Liver function: Child's A or B (score < 7)
排除标准
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •underlying serve cardiac or renal diseases
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Patients ineligible for hepatic artery embolization
研究组 & 干预措施
TACE-HAIC
hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion
干预措施: TACE-HAIC (Drug)
HAIC
FOLFOX-based chemotherapy hepatic artery infusion
干预措施: HAIC (Drug)
结局指标
主要结局
progression-free survival
时间窗: 6-12 months
Time to progression, last follow-up or death after random assignment to TACE-HAIC or HAIC
次要结局
- overall survival(6-12 months)
- Downstage hepatectomy rate(6-12 months)
研究者
Yunfei Yuan
Professor
Sun Yat-sen University
