Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Progression-free survival, PFS
研究概览
简要总结
Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE).
Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC.
Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate.
Whether TACE-HAIC would improve survival for patients with PVTT is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.
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;
- •Patients with resectable primary hepatocellular carcinoma and portal vein tumor thrombus, which was not located in main portal vein;
- •Child-Pugh A or B (7 score) liver function;
- •With more than 3 months expected survival;
- •The volume of residual liver more than 30%
排除标准
- •Patients with primary hepatocellular carcinoma and major portal vein tumor thrombus
- •With extrahepatic metastasis or unresectable HCC
- •Pregnant woman or sucking period;
- •With other malignant cancer;
- •Received chemotherapy, target therapy or immunosuppressive drugs therapy before this study.
结局指标
主要结局
Progression-free survival, PFS
时间窗: 36 months
PFS was calculated from the date of starting treatment to the date of progression, of disease or death.
次要结局
- Overall survival, OS(60 months)
研究者
Yunfei Yuan
Professor
Sun Yat-sen University