Neoadjuvant Radiotherapy for Patients With Hepatocellular Carcinoma Involving Type I Portal Vein Tumor Thrombus
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. Moreover, few retrospective studies also found neoadjuvant radiotherapy (PMID: 27317960) may improve overall survival for HCC patients involving type II/III PVTT. However, the safety and efficacy of neoadjuvant raidotherapy for HCC involving type I PVTT is unknown.
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
- 是
入选标准
- •Age 18-75 years;
- •Patients with resectable primary hepatocellular carcinoma and Cheng's type I portal vein tumor thrombus;
- •Child-Pugh A or B (7 score) liver function;
- •With more than 3 months expected survival;
- •The volume of residual liver more than 30%;
- •Patients agree to take part in.
排除标准
- •Patients with primary hepatocellular carcinoma and Cheng's type II/III/IV portal vein tumor thrombus
- •Previous history of epigastric radiotherapy
- •With extrahepatic metastasis
- •With radiotherapy contraindication;
- •Pregnant woman or sucking period;
- •With repture tumor;
- •With other cancer in previous five years;
- •With chemothrapy, target therapy or immunosuppressive drugs therapy.
结局指标
主要结局
Overall survival
时间窗: 1 year
From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.
次要结局
- Recurrence-free survival(1 year)
研究者
Jian-Hong Zhong
Principal Investigator
Guangxi Medical University