RCT Research: the Treatment of Hepatic Carcinoma With Portal Vein Branch Tumor Thrombosis (Resection or Sorafenib)
试验速览
- 阶段
- 4 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- overall survival of 1 year
研究概览
简要总结
According to the guidelines recommended, only a few new targeted therapy drugs treatment, such as Sorafenib, is proper. It's 3 year survival rate is only 8% or so. According to our previous study, patients with hepatic carcinoma without portal vein tumor thrombus backbone and the contralateral tumor thrombus applyed tumor excision, along with tumor thrombus, the 3 year survival rate can reach 39.9%, the 5-year survival rate can reach 22.7%, curative effect is obviously better.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Hepatic cellular Carcinoma.
- •Patients with Portal Vein Tumor Thrombus (PVTT) of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI.
- •Patients with a solitary tumor or multiple tumor which are resectable.
- •Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.
- •Patients without surgical contraindication.
- •Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) < 10% before treatment.
- •Laboratory examination: haemoglobin (Hb)>100g/L, white blood cell (WBC) > 3000/mL, PLT > 8×10*10/L before treatment.
- •Patients without severe esophagealgastric varices before treatment.
- •Patients with HBV，HBV DNA≤100, 000 copy/mL.
- •All of the patients has written consent for this research.
排除标准
- •1.Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.
- •2.Patients with surgical contraindication. 3.Patients with Child C grade liver function before treatment. 4.Patients with other malignancy. 5.Patients treated with hepatic resection or TACE before this treatment. 6.Patients with severe esophagealgastric varices or refractory ascites or coagulation dysfunction before treatment.
研究组 & 干预措施
PVTT WITH OPERATION
patients suitable for surgery
干预措施: surgery (Procedure)
PVTT WITH SORAFENIB
AASLD recommend therapy:
sorafenib tablet, 400mg, bid.
干预措施: Sorafenib (Drug)
结局指标
主要结局
overall survival of 1 year
时间窗: 1 years
including 3, 6, and 12 months overall survival (OS) rate
overall survival of 3 year
时间窗: 3 years
including 1, 2, and 3 years overall survival (OS) rate
次要结局
- time to progression(3 years)
研究者
Xiaoping Chen
Professor
Huazhong University of Science and Technology