NCT04434989招募中不适用
Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of SBRT for perivascular hepatocellular carcinoma, compared with RFA.
详细描述
The primary endpoint is 1-year local recurrence rate and disease-free survival. We planned to recruit 170 patients who diagnosed as perivascular hepatocellular carcinoma. The patients will be randomized into SBRT group and RFA group as 1:1 ratio.
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
- •Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative treatment.
- •Unifocal tumor ≤5cm
- •Closed to great vessels (diameter ≥3mm)
- •ECOG score 0-1
- •Child-Pugh grade A or B7
- •Sufficient liver and kidney function
排除标准
- •Vascular invasion
- •Extra-hepatic metastasis
- •Received TACE before
- •Inflammation of local skin
- •Dysfunction of liver, kidney or bone marrow.
- •Concomitant other malignant tumor or HIV infection
结局指标
主要结局
Disease-free survival
时间窗: 2 years
The duration between radomization and recurrence, progression or death
1-year local recurrence rate
时间窗: 1 year
The rate of participants who have recurrence in treating area in 1 year to all the participants
次要结局
- Overall survival(2 years)
- 2-year recurrence rate(2 years)
- Adverse events(2 years)
研究者
Ming Kuang
Vice President
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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