Efficacy and Safety of Combination of Sorafenib as Preoperative Adjuvant and Latter Radiofrequency Ablation in the Treatment Of Recurrent Hepatocellular Carcinoma: A Prospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.
详细描述
Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study. Eligible cases will be assigned into the experimental group and the control group. For experiment group, sorafenib tablet will be given for two weeks, and then perform radiofrequency ablation. For the control group, RFA will be performed immediately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Aged from 18 to 75 years old
- •Without gender restriction
- •With a favorable liver function of Child-Pugh A to B
- •No contraindications to RFA and anesthesia
- •Diagnosed with Recurrent HCC
- •Signed informed consent.
排除标准
- •Cancer thrombosis in major vessels/ extrahepatic metastasis
- •Uncontrollable ascites or variceal bleeding
- •Impairment in liver function
- •Severe disorders in vital organ
- •Accompanied with other tumors or infectious disease except hepatitis.
研究组 & 干预措施
Sorafenib+RFA group
for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation
干预措施: RFA (Procedure)
Sorafenib+RFA group
for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation
干预措施: Sorafenib (Drug)
RFA group
for eligible cases, RFA will be given only.
干预措施: RFA (Procedure)
结局指标
主要结局
Disease free survival
时间窗: 1 year
1 year Disease free survival
次要结局
- Time To Recurrence(3 year)
- Overall Survival(3 year)
- postoperative complications(6 months)
- Health economics index(3 years)
- mortality(3 months)
研究者
feng xiaobin
Clinical Professor
Southwest Hospital, China