Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Barcelona Clinic Liver Cancer (BCLC) B Stage: 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
- 280
- 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. Although BCLC (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE) for BCLC B stage patients, increasing studies suggested that hepatic resection provided survival benefit for those patients. However, a relative high recurrence risk leads surgeons to investigate the value of preoperative treatment.
Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable 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 BCLC B stage 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;
- •BCLC B stage and tumor number <=4;
- •Patients with resectable primary hepatocellular carcinoma;
- •Child-Pugh A or B (7 score) liver function;
- •The volume of residual liver more than 30%
排除标准
- •• With unresectable HCC
- •Pregnant woman or sucking period;
- •With other malignant cancer;
- •Received anti-HCC 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