Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion with Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT), but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not benefit much from sorafenib in previous studies. There is no established standard treatment for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis.
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
- 否
入选标准
- •Patient must have histologically or clinically confirmed hepatocellular carcinoma.
- •HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein)
- •Child A class
- •Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%)
- •Absolute neutrophil count >= 1,500/mcL
- •Platelets >= 100,000/mcL
- •Hemoglobin >= 90g/L
- •Total bilirubin =< 2 X institutional upper limit of normal
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normality
- •Creatinine =< 1.5 X institutional upper limit of normal
- •Albumin >= 30g/L
- •Patient must be able to understand and willing to sign a written informed consent document
排除标准
- •Patients who have had prior chemotherapy with Oxaliplatin or Fluorouracil or sorafenib.
- •Patient who is receiving any other investigational agents
- •Patient who have a diagnosis of hepatic encephalopathy
- •Patients who have a diagnosis of sclerosing cholangitis.
- •Patients who have a diagnosis of Gilbert's disease.
- •Patients who have clinical ascites
- •Patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements
- •No other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years
- •Patient who is pregnant or lactating
- •Patient Allergic to Iodine contrast medium
- •Uncontrolled severe coagulation disorders (INR < 1.5 in patients not on warfarin therapy)
研究组 & 干预措施
Sor-HAIC group
400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks.
干预措施: HAIC (Procedure)
Sor-HAIC group
400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks.
干预措施: Sorafenib (Drug)
Sor group
400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Overall survival
时间窗: 1 year
次要结局
未报告次要终点
研究者
Xiaodong Wang, MD
Chief Physician, Associate Professor
Peking University