EUCTR2011-006194-26-ES进行中（未招募）不适用
A phase IV, multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of Sorafenib in patients with hepatocellular carcinoma after radiological progression - SOPRAC
JOSE LUIS MONTERO ALVAREZ0 个研究点开始时间: 2012年2月13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
- •1. Male or female patient older than 18 years old.
- •2. Diagnosis of advanced HCC according to the AASLD Guidelines.
- •3. HCC stage B with contraindication to transarterial chemoembolization (TACE) or stage C according to Barcelona Clinic Liver Cancer (BCLC) staging classification.
- •4. Sorafenib treatment-naive patient.
- •5. Child-Pugh class A (5-6 points) or class B (7 points), without ascites (mild ascites controlled with diuretics is allowed) and encephalopathy. Child-Pugh status must be calculated based on clinical findings and laboratory results during 30 days before inclusion in the study.
- •6. ECOG Performance Status lower than 2.
- •7. Adequate liver, renal and bone marrow function as shown by:
- •AST y ALT lower than 5 x ULN (upper limit of normal); bilirubin lower than 2 mg/dL; INR lower than 2; absolute neutrophil count (ANC) higher than 1.2 x 103 per ml ; platelets higher than 70 x 103 per ml ; serum creatinine lower than 1.5 mg/dL.
- •8. Written informed consent.
- •9. Women of chilbearing potential (WOCBP) must have a negative serum pregnancy test performed in the screening visit.
- •WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilizatiion (hysterectomy, bilateral tubal ligation or bolateral oophorectomy) or is not postmenopausal. Post menopause is defined as an amenorrhea state longer than 12 consecutive months.
- •10. Men and women enrolled in this trial must used adequate barrier bith control measure since two weeks prior to the start of investigational product, during the course of the trial and two weeks after the last dose of investigational product.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
排除标准
- •1. Prior liver transplantation.
- •2. Known history of HIV infection.
- •3. Previous/concurrent cancer (distinct from HCC) known during the last 3 years, except for cervical carcinoma in situ, basal cells carcinoma and superficial bladder tumors.
- •4. History of cardiovascular disease:
- •- uncontrolled hypertension, defined as systolic blood pressure higher than 150 mmHg or diastolic pressure higher than 90 mmHg despite optimal medical management.
- •- active coronary disease, unstable or newly diagnosed angina or myocardial infarction less than 12 months prior to study entry.
- •- cardiac arrhythmias requiring anti-arrhytmic therapy other than beta blockers or digoxin.
- •- congestive heart failure higher than NYHA class 2.
- •5. Subjects with history of bleeding diathesis.
- •6. History of gastrointestinal bleeding within 30 days of randomizaion.
- •7. Subjects with a history of esophageal varices bleeding without efffective therapy and/or treatment to prevent bleeding recurrence.
- •8. Abuse to drugs, clinical or psychological states that might interfere in the participation or evaluation of study results.
- •9. Subjects on warfarin, acenocumarol, fenprocumone.
- •10.Female patients who are pregnant or breast feeding.
- •11.Unable or unwilling subjects to give informed consent.
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