Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-term Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- disease free survival
研究概览
简要总结
Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly influence it's prognosis, especially for the patient with tumor >5cm, multiple tumor and who cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted into the liver incisal margin after tumor was resected could reduce the recurrence rate of HCC after liver resection.According to this, we proceed this RCT to prospectively observe the effect of sustained released 5-FU,and we also want to know whether combined with sustained released cisplatin will get better effect in preventing the tumor recurrence,especially in short time after liver resection.
详细描述
150 HCC patients with tumor >5cm, multiple tumor and who cannot accept R0 resection will be randomized divided into 3 groups. Group A (50 cases) will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected. Group B (50 cases) will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin. Group C (50 cases) will be the controlled one which will not be implanted any chemotherapeutic drugs. All patients will accepted TACE 30 days after liver resection. We will follow up all patients until they are dead or missed connected. Related adverse reaction will be recorded. Total survival time (TST) and disease free survival time (DFST) will be calculated too. At the end of the study we will compare the difference of adverse reaction, complication, TST and DFST between the 3 groups. According to the result we will estimate these drugs' antitumor effect and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •tumor >5cm;
- •multiple tumor located in one liver lobe;
- •margin of tumor is not clear;
- •cutting edge to tumor <1cm;
- •portal vein branch invasion;
- •without extra-liver metastasis;
- •patient's liver function and condition is able to accept hepatectomy.
排除标准
- •single tumor <=5cm;
- •multiple tumor located more than in one liver lobe;
- •margin of tumor is clear;
- •cutting edge to tumor >=1cm;
- •portal vein stem invasion
- •extra-liver metastasis;
- •patient's liver function and condition cannot accept hepatectomy.
研究组 & 干预措施
5-FU+Cisplatin
50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected.
干预措施: sustained released 5-FU and sustained released cisplatin (Drug)
5-FU+Cisplatin
50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected.
干预措施: TACE (Procedure)
5-FU
50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected.
干预措施: sustained released 5-FU (Drug)
5-FU
50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected.
干预措施: TACE (Procedure)
control
干预措施: TACE (Procedure)
结局指标
主要结局
disease free survival
时间窗: 2 years
次要结局
- overall survival(2 years)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospotal
Eastern Hepatobiliary Surgery Hospital