An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Time to Progression (Efficacy)
研究概览
简要总结
The investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion.
详细描述
TACE is an established therapy for patients with unresectable hepatocellular carcinoma (HCC) and has been shown to significantly improve survival in these patients compared to no treatment. Moreover, TACE can be performed safely and may improve the overall survival of patients with HCC and major branch of portal vein invasion. Sorafenib, already approved for HCC, could lead to significantly improvement in tumor control and survival in patients with advanced stage HCC. So far there are no head to head comparison reports about the efficacy of Sorafenib and TACE. Here the investigators evaluate the efficacy of sorafenib and TACE in advanced HCC with major branch of portal vein 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •80 > Age >= 18 years.
- •Child-Pugh class A (class B could be included when Childs score is 7).
- •Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or MRI
- •not only newly diagnosed treatment-naive patients,
- •but also HCC patients previously treated with other therapies in case of development of major branch of portal vein invasion
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
- •White blood cell counts (WBC) >= 2,000 /μl, Absolute neutrophil count (ANC) > 1,200/μl
- •Hemoglobin >= 8.0 g/dl
- •Platelet count > 50,000/μl
- •Serum creatinine < 1.7 mg/dl
- •Total bilirubin =< 3.0 mg/dl
- •Prothrombin Time (PT)-international normalized ratio (INR) =< 2.3 or Prothrombin Time (PT)-sec =< 6 sec
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
排除标准
- •Child-Pugh score >=
- •Age < 18 or >= 80 years.
- •ECOG Performance Status >=
- •Recipient of living donor or deceased donor liver transplantation
- •Patients unable to understand the contents of informed consent or refuse to sign the informed consent.
- •Patients with evidence of uncontrolled or severe medical conditions requiring treatment.
研究组 & 干预措施
Sorafenib
Sorafenib 400mg po bid
干预措施: Sorafenib (Drug)
TACE for HCC with portal vein invasion
Antineoplastic agents are directly injected into the hepatic artery, allowing high intratumoral concentrations of drugs and thereby reducing systemic side effects. The mixture of chemotherapeutic agents and iodized oil is almost completely retained in neoplastic nodules and can remain in HCC tissue for a long time. Subsequent mechanical embolization of the artery feeding the neoplasm causes ischemic damage to the tumor and prolongs the duration of the effects of chemotherapeutic agents.
干预措施: TACE for HCC with portal vein invasion (Procedure)
结局指标
主要结局
Time to Progression (Efficacy)
时间窗: every 6 weeks up to 3 years
次要结局
- objective tumor control rate(every 6 weeks up to 3 years)
- progression-free survival(every 6 weeks up to 3 years)
- overall survival(every 6 weeks up to 3 years)
- objective tumor response rate(every 6 weeks up to 3 years)
- the adverse event rate and examine the toxicities(every 6 weeks up to 3 years)
- Change of perfusion parameter(every 6 weeks up to 3 years)
- Alpha feto protein (AFP) responsiveness(every 6 weeks up to 3 years)