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临床试验/NCT03591705
NCT03591705招募中不适用

Transarterial Chemoembolization Versus Transarterial Chemoembolization With Hepatic Artery Chemotherapy Infusion for Patients With Potentially Resectable HCC

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年7月6日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion

干预措施: TACE-HAIC (Drug)

HAIC

Active Comparator

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

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yunfei Yuan

Professor

Sun Yat-sen University

研究点 (1)

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