Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 3-year overall survival
研究概览
简要总结
This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE) for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided into two group.One group will receive hepatic resection, while an another equivalent group patients will be treated with Transarterial Chemoembolization.
详细描述
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver.For Barcelona Clinic Liver Cancer (BCLC) stage B patients，especially those with Solitary Huge Tumor (≥5cm) ，the better therapy between hepatic resection and transarterial chemoembolization remains controversial despite extensive studies。 From now on, we prospectively collected patients with solitary huge HCC who received hepatectomy or TACE. Of the 200 patients，100 patients were surgically treated and the others underwent TACE。After the treatment, patients received routine follow-up with physical examination, serum α-fetoprotein (AFP) level and ultrasonography at 3-month intervals for the first year and then every 6 months.The end of follow-up was determined as either the time of last follow-up (July 2019) or death. The overall survival，including 1, 2 and 3-year overall survival rates，will be analyse. All data are collected prospectively.
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
- Double (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 Solitary Huge Tumor (≥5cm）of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI.
- •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, blood platelet counts (PLT) > 8×10*10/L before treatment.
- •Patients without severe esophagogastric 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
- •Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.
- •Patients with surgical contraindication.
- •Patients with Child C grade liver function before treatment.
- •Patients with other malignancy.
- •.Patients treated with hepatic resection or TACE before this treatment.
- •Patients with severe esophagogastric varices or refractory ascites or coagulation dysfunction before treatment.
研究组 & 干预措施
Hepatic resection
Indications for Hepatic resection were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy.
干预措施: hepatic resection (Procedure)
Transarterial Chemoembolization(TACE)
Transarterial Chemoembolization is performed in less than one week after clinical diagnosis.
干预措施: TACE (Procedure)
结局指标
主要结局
3-year overall survival
时间窗: 3 years
Overall survival rate will be evaluated at 3 years after treatment
次要结局
- 1-year overall survival(1 years)
- 2-year overall survival(2 years)
- Recurrence rates(3 years)
研究者
Xiaoping Chen
Professor
Huazhong University of Science and Technology