EUCTR2008-006021-14-IT进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
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
- •> Patients with histological or cytologically documented HCC or clinical diagnosis by AASLD criteria in cirrhotic subjects is required. For subjects without cirrhosis histological 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. 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, Sogrens syndrome) including congenital abnormality (e.g. Fuchs 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 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. Myocardial infarction more than 6 months prior to study entry is permitted. (See Appendix 10.7) 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
相似试验
进行中（未招募）
1 期
A clinical trial to determine the efficacy and safety of Presendin in idiopathic intracranial hypertensioMedDRA version: 23.1Level: PTClassification code 10078904Term: Idiopathic intracranial hypertensionSystem Organ Class: 10029205 - Nervous system disordersIdiopathic intracranial hypertensionEUCTR2021-006664-24-FRInvex Therapeutics Ltd.240
进行中（未招募）
1 期
A clinical trial to determine the efficacy and safety of Presendin in idiopathic intracranial hypertensioMedDRA version: 23.1Level: PTClassification code 10078904Term: Idiopathic intracranial hypertensionSystem Organ Class: 10029205 - Nervous system disordersIdiopathic intracranial hypertensionEUCTR2021-006664-24-DEInvex Therapeutics Ltd.240
已完成
3 期
A Phase 3 study of KW-3357 in patients with early onset severe preeclampsiaPreeclampsiaJPRN-jRCT2080224912Kyowa Kirin Co., Ltd180
进行中（未招募）
1 期
Evaluation of the combination of Nexavar and Tarceva for the treatment of liver cancer.To evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotibib 150 mg once a day in subjects with unresectable advanced or metastatic Child-Pugh A HCC.MedDRA version: 14.0 Level: LLT Classification code 10019829 Term: Hepatocellular carcinoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-006021-14-BGBayer HealthCare AG, 51368 Leverkusen, Germany720
进行中（未招募）
1 期
Evaluation of the combination of Nexavar and Tarceva for the treatment of liver cancer.To evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotibib 150 mg once a day in subjects with unresectable advanced or metastatic Child-Pugh A HCC.MedDRA version: 13.1Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 13.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-006021-14-BEBayer HealthCare AG, 51368 Leverkusen, Germany700