Adjuvant Transarterial Chemoembolization With or Without Sorafenib for Patients With Hepatocellular Carcinoma and Microvascular Invasion
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Overall survivals
研究概览
简要总结
Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Though prognosis for patients with HCC is generally poor, hepatic resection can be an effective curative treatment, and its indications have been expanding in recent years. Resection can be reasonably safe and effective even for patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as high as 74% for patients with intermediate and advanced HCC after resection. Microvascular invasion is one of the main risk factors which influence risk of HCC recurrence and patient prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after resection is so important to improve patient prognosis.
Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in reducing early recurrence rate and mortality for patients with HCC with risk factors of recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular invasion.
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
- 是
入选标准
- •Age 18-75 years
- •Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
- •Patients with microvascular invasion by histopathological examination of surgical samples
- •Patients have Child-Pugh A or B liver function
- •No previous neoadjuvant treatment
- •No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
- •No malignancy other than HCC for 5 years prior to the initial HCC treatment
排除标准
- •History of cardiac disease
- •Known history of human immunodeficiency virus (HIV) infection
- •Known Central Nervous System tumors including metastatic brain disease
- •History of organ allograft
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- •Pregnant or breast-feeding patients
研究组 & 干预措施
TACE
Transarterial chemoembolization (TACE) is performed two to four weeks after hepatic resection.
干预措施: TACE (Procedure)
TACE
Transarterial chemoembolization (TACE) is performed two to four weeks after hepatic resection.
干预措施: empty control (Other)
sorafenib
Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection.
干预措施: Sorafenib (Drug)
TACE plus sorafenib
Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection. At the same time, TACE is performed two to four weeks after hepatic resection.
干预措施: TACE plus sorafenib (Drug)
TACE plus sorafenib
Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection. At the same time, TACE is performed two to four weeks after hepatic resection.
干预措施: empty control (Other)
结局指标
主要结局
Overall survivals
时间窗: 1 year
次要结局
- Hospital mortality(30-day)
- Recurrence rates(1 years)
研究者
Jian-Hong Zhong
Guangxi Medical University
Guangxi Medical University