EUCTR2008-006021-14-BG进行中（未招募）1 期
A Phase III randomized, placebo controlled, double blind trial of Sorafenib plus Erlotinib vs. Sorafenib plus placebo as First Line systemic treatment for Hepatocellular Carcinoma (HCC) - SEARCH
Bayer HealthCare AG, 51368 Leverkusen, Germany0 个研究点目标入组 720 人开始时间: 2009年8月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 720
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
入选标准
- •Patients with histological or cytologically documented HCC or clinical diagnosis by AASLD criteria in cirrhotic subjects is required. For subjects without cirrhosis histological or cytological confirmation is necessary.
- •Patients must have at least one tumor lesions that meets both of the following criteria:
- •- Lesion can be accurately measured in at least one dimension according to RECIST
- •- Lesion has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation
- •Patients who have received local therapy are eligible. Local theapy must be completed at least 4 weeks prior to the baseline scan. Previously treated lesions will not be selected as target lesions.
- •Patients with an ECOG PS of 0 or 1.
- •Cirrhotic status of Child-Pugh Class A.
- •Following Laboratory Parameters (as assessed by Central Laboratory):
- •- Platelet count = 60 x 109/L
- •- Hemoglobin = to 8.5 g/dl
- •- Total Bilirubin = 2.8 mg/dl
- •- ALT and AST = 5 x ULN
- •- Serum Creatinine = 1.5 x ULN
- •- PT international normalized ration (INR) = 2.3 or PT = 6 seconds above control
- •- Patients who are being therapeutically anticoagulated with an agent such as wafarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists and these patients have a Child-Pugh score = 6 during screening.
- •Patients must provide written informed consent prior to any study procedures being performed
- •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
- •Renal failure requiring hemo- or peritoneal dialysis
- •Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) – related illness or serious acute or chronic illness.
- •Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren’s syndrome) including congenital abnormality (e.g. Fuch’s dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test).
- •Child-Pugh class B or C
- •Previous treatment with yttrium- 90 spheres
- •Clinically significant (i.e. symptomatic) peripheral vascular disease
- •History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension defined as systolic blood pressure>150mmHg or diastolic blood pressure>90 mmHg despite optimal medical management. Myocardial infarction more than 6 months prior to study entry is permitted. (See Appendix 11.6)
- •History of interstitial lung disease (ILD)
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
- •Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), except HBV/HCV infections
- •Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
- •Pregnant or breast-feeding patients.
研究者
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