NCT01572324已完成2 期
Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas
Peking University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Response rates
研究概览
简要总结
This Phase II clinical trial is to study the effectiveness and safety of continuous hepatic arterial infusion (HAI) of Oxaliplatin and Fluorouracil in Patients with Unresectable Biliary tract carcinomas, and to explore a better first-line treatment regimen for these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have histologically or cytologically confirmed Biliary tract carcinomas including intrahepatic, hilar cholangiocarcinoma and gallbladder cancer without evident liver metastasis.
- •Patient must have locally advanced disease that is unresectable after review by the Hepatobiliary Surgery service
- •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 and other antitumor therapy treatment
- •Patient who is receiving any other investigational agents
- •Patient who have evident distant (M) disease;
- •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
Arterial infusion
Experimental
干预措施: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine (Drug)
结局指标
主要结局
Response rates
时间窗: 4 months
Describe the overall response rate with a 95% confidence interval.
次要结局
- Toxicity of HAI(1 months)
- Overall survival(3 years)
- Progress free survivial(2 years)
研究者
Xiaodong Wang, MD
MD
Peking University
研究点 (1)
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