Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Two-year overall survival rate
研究概览
简要总结
To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus.
详细描述
No standard treatment has been established for highly advanced hepatocellular carcinoma (HCC) invading the major branches of the portal vein except for sorafenib. Some reports suggested that hepatic arterial infusion chemotherapy improved survival of these patients. Other reports indicated surgical intervention improved that survival. However, there is no standard adjuvant therapy after liver resection for the patients with HCC with portal vein tumor thrombus in the main or first branch of the portal vein. Our preliminary results showed that combined interferon-alpha and intra-arterial 5-fluorouracil (5-FU) as a postoperative therapy prolonged disease-free and overall survival after liver resection. Hepatic arterial infusion chemotherapy using low-dose 5-FU and cisplatin is also promising regimen for advanced HCC.
Herein, the investigators planed the study to evaluate efficacy (two year survival as primary outcome, and overall-survival as secondary outcome) and safety ( as secondary outcome) in hepatic arterial infusion chemotherapy with continuous infusion of 5-fluorouracil and systemic administration of interferon-alpha or low-dose 5-FU and cisplatin, and to compare the efficacy as randomized control trial.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI.
- •surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
- •20 years old or more.
- •Eastern Cooperative Oncology Group Performance status of 0 or
- •Life expectancy of at least 6 months at the pre-treatment evaluation.
- •Child-Pugh class A or B.
- •Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.
- •white blood cell count >= 2000/microliter, Neutrophil >= 1000/microliter, Hemoglobin >= 9.0 g/dL, Platelet count >= 75000/microliter, Total Bilirubin <= 1.5mg/dl, aspartate aminotransferase(AST) /alanine aminotransferase(ALT) <= 150 IU/L, Serum creatinine <= 1.2mg/dL, Creatinine clearance >= 60 ml/min
排除标准
- •Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
- •Extrahepatic tumor spread which affects patient's prognosis.
- •Hepatic encephalopathy
- •Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV).
- •Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
- •Active double cancer
- •Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics.
- •others, in the investigator's judgment.
研究组 & 干预措施
Interferon Alfa、Fluorouracil
Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks
Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
干预措施: Interferon Alfa、Fluorouracil (Drug)
Cisplatin、Fluorouracil
Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks
Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks
干预措施: Cisplatin、Fluorouracil (Drug)
结局指标
主要结局
Two-year overall survival rate
时间窗: Two years
Duration: From randomization to evidenced death. Rate: Number of patients with evidenced death / number of total patients. 2 year survival rate: survival rate at two-year from the randomization
次要结局
- Overall survival time(two years)
- toxicity(At the end of hepatic arterial infusion chemotherapy (6 months))
- Progression free survival time(two years)