A Randomized Controlled Study on the Effect of S-Adenosyl Methionine Treatment on Anti-tumor Recurrence After Curative Resection of Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to tumor recurrence
研究概览
简要总结
The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after curative resection of Hepatocellular Carcinoma.
详细描述
Hepatocellular carcinoma (HCC) is now a major health problem. Although the recent advances in treatment of HCC have significantly improved the prognosis of patients with HCC, the overall survival rate is still unsatisfactory; the 5-year survival rate is only 50-70% even after curative treatment such as hepatic resection and percutaneous radiofrequency ablation. One of the reasons for the poor prognosis of HCC is its high rate of recurrence.However,anti-relapse treatment remains a pressing work to do.
In recent years, some study reported that S-Adenosyl Methionine had an impact on promoting apoptosis and inhibiting the growth on breast cancer, colon cancer,gastric cancer and liver cancer in vitro and vivo.
In this study, we aim to examine whether S-Adenosyl Methionine have an effect on improving patients' recurrence after curative resection of Hepatocellular Carcinoma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 18 years and <=70 years of age
- •Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD)
- •Within Milan criteria
- •Without or mild liver cirrhosis and the liver function is Child A class.
- •Without any other treatments such as TACE、PEI、PRFA before the surgery
- •No evidence for extrahepatic metastasis
排除标准
- •Patients with macro tumor thrombus or extrahepatic metastasis.
- •Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction.
- •Subjects accepting other trial drugs or participating in other clinical trials.
- •Patients refuse to join our trial.
- •Female with pregnancy or during the lactation period.
研究组 & 干预措施
S-Adenosyl Methionine Treatment
Patients will be treated with S-Adenosyl Methionine treatment after curative resection.
干预措施: S-Adenosyl Methionine (Drug)
结局指标
主要结局
Time to tumor recurrence
时间窗: 5 years
次要结局
- Overall survival(5 years)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital