EUCTR2010-024306-36-SE进行中（未招募）1 期
An exploratory study of sorafenib for patients listed for transplantation due to HCC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
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 HCC without prior medical anti-tumour therapy, basically eligible for LTx at screening. Tumour size according to the UCSF criteria are allowed.
- •HCC diagnosed by histology or according to non-invasive European Association for the study of the liver (EASL) criteria (only cirrhotic patients):
- •1. radiological criteria: two coinciding imaging techniques: Focal lesion >2 cm with arterial hypervascularization in a cirrhotic liver
- •2. Combined criteria: one imaging technique associated with alpha-fetoprotein (AFP): Focal lesion > 2 cm with arterial hypervascularization + AFP levels> 400 ng/ml
- •Pretreatment CT or MRI without evidence of radiographically definable vascular invation or extrahepatic disease, not older that 6 weeks
- •Sufficient hematologic, liver and renal function
- •PT-INR/PTT < 1,5 ULN
- •No acute infections at time of therapy initiation
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Child-Pugh socre more than 7p at time of inclusion
- •Expected waiting time for transplantation below three months
- •Residual radiological definiable extrahepatic disease, portal vein involvement or lymph node involvement on CT, MRI or bone scan. Patients who are not potentially eligible for LTx are excluded
- •Patients with prior or concomitant systemic anticancer therapy
- •Patients with significant cardiovascular disease such as myocardial infarction, chronic heart failure or unstable coronary artery disease
- •Patints with severe pulmonary disease that would be hazardous for LTx
- •Uncontrolled hypertension, defined as systolic blood pressure >150 mg Hg or diastolic pressure >90 mm Hg, dispite optimal management
- •Thrombotic or embolic events including transient ischemic attacks within the pas 6 months
- •Patients with previous malignancy, within 5 years prior treatment, other then carcinoma in situ of the skin and the cervix. Previous HCC, treated locally with ablation or resection is permitted
- •Patients <18 years
- •Pregnant or breast-feeding patients. Both men and women must use adequate barrier birth control measures.
- •Patients with uncontrolled infections or HIV sero-positive patients
- •History or hypersensitivity to the investigational medicinal product
- •Mental conditions rendering hte patient incapable to understand the nature, scope and consequences of the study
- •No patient will be allowed to enroll in this study more than once
- •Prior organ transplantation
- •Concomitant immunosuppressive treatment
- •Participation in other pharmaceutical clinical trials
研究者
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