EUCTR2010-020678-41-IT进行中（未招募）不适用
SE OF SORAFENIB IN THE PREVENTION OF RELAPSE OF RESECTED/ABLATED HEPATOCELLULAR CARCINOMA (HCC) IN PATIENTS WITH HEPATITIS C VIRUS CHRONIC INFECTION. - ND
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE0 个研究点开始时间: 2010年9月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Adult patients (age =70; = 18).
- •? Anti-HCV, HCV RNA positivity.
- •? Surgical resection or percutaneous tumor ablation procedures at least two weeks before.
- •? Child A or B cirrhosis.
- •? Performance status ECOG 0-2.
- •? No prior targeted anti-angiogenetic therapy or at least 4 weeks since prior systemic chemotherapy.
- •? At least 4 weeks since prior antiviral therapy
- •? Not pregnant women.
- •? No significant renal impairment (creatinine clearance < 30mL/min) or patients on dialysis.
- •? No current infections requiring antibiotic therapy.
- •? Not on anticoagulation or suffering from a bleeding disorder.
- •? No unstable coronary artery disease or recent myocardial infarction.
- •? Platelet count = 40,000/µL.
- •? Hemoglobin = 8.0 g/dL.
- •? Total bilirubin = 3 mg/dL
- •? AST and ALT= 5x normal upper limits.
- •? PT INR = 2.3 or PT = 6 seconds
- •? Absolute neutrophil count = 1,500/mm3.
- •? Ability to understand the protocol and to agree to and sign a written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous or concurrent cancer distinct from HCC, except any cancer curatively treated > 3 years prior to entry in the study.
- •? Renal failure requiring hemo- or peritoneal dialysis.
- •? Child-Pugh C hepatic impairment
- •? History of cardiac disease: > New York Heart Association (NYHA) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
- •? Active clinically serious infections.
- •? Other viral infections (HBV, HIV).
- •? Known central nervous system tumors including metastatic brain disease.
- •? History of organ allograft.
- •? Substance abuse (current), psychological or social conditions that may interfere with the patient`s
- •participation in the study or evaluation of the study results.
- •? Known or suspected allergy to the investigational agents given in association with this trial.
- •? Patients unable to swallow oral medications.
- •? Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
- •? Cardiac ventricular arrhythmias.
- •? Uncontrolled hypertension (> 159/90 mmHg) despite optimal medical management.
- •? Thromboembolic events such as cerebrovascular accident, including transient ischemic attacks within the past 6 months.
- •? Any hemorrhage/bleeding event within 4 weeks of first dose of study drug.
- •? Major surgery within 6 weeks of start of study drug.
- •? Radiotherapy during study or within 3 weeks prior to start of study drug.
研究者
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