NCT01055743Unknown2 期
A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS).
研究概览
简要总结
This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of stage I hepatocellular carcinoma
- •Child-Pugh class A, B
- •Radical resection is feasible
- •Patients with adequate renal, hepatic, and hematologic function
- •Written informed consent
排除标准
- •Allergic to chemotherapy drugs
- •No measurable lesion
- •Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment
- •Evidence of serious infection
- •Renal or hepatic dysfunction, significant cardiovascular disease
- •Pregnant or lactating women
研究组 & 干预措施
Radical resection
Active Comparator
干预措施: Radical resection (Procedure)
Radical resection + Fluorouracil Implants
Experimental
干预措施: Radical resection (Procedure)
Radical resection + Fluorouracil Implants
Experimental
干预措施: Fluorouracil Implants (Drug)
结局指标
主要结局
To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS).
时间窗: 1, 2, and 3 years
次要结局
- Quality of Life(from baseline to the last visit)
- Incidence Rate of Complications(1, 2, and 3 years)
- Adverse Events(from the beginning of treatment to the end of study)
研究者
研究点 (1)
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