EUCTR2008-001401-42-AT进行中（未招募）1 期
Combination of Erlotonib plus Sorafenib in Patients with unresectable Hepatocellular Carcinoma; a randomized placebo controlled Phase II pilot trial. - Erlosora-1
Medizinische Universität Wien, Univ. KlM III, Klinische Abt. f. Gastroenterologie/Hepatologie0 个研究点目标入组 90 人开始时间: 2008年6月3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
- 90
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) Patients with the clinical stage C according to the Barcelona Clinic Liver Cancer Staging System
- •2 Patients with the clinical stage B according to the Barcelona Clinic Liver Cancer Staging System who have a contraindication for transarterial chemoembolisation (TACE) or who are non-responders to TACE
- •3) Age > 18 years.
- •4) ECOG Performance Status of 0-2
- •5) Life expectancy of at least 12 weeks.
- •6) Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by CT-scan or MRI
- •7) Child Pugh A or B (max. 9 points)
- •8) Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior start of therapy:
- •Hemoglobin > 8.5 g/dl
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Platelet count ? 60,000/µl
- •Total bilirubin < 5 mg/dl
- •ALT and AST < 5 x upper limit of normal
- •Normotest >40% [Patients who are being therapeutically anticoagulated with an agent such as coumarin-derivative or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
- •Serum creatinine < 1.5 x upper limit of normal.
- •9) Signed and dated informed consent at the beginning of the study.
- •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
- •1) Patients with the clinical stage A or D according to the Barcelona Clinic Liver Cancer Staging System
- •2) Patients with the clinical stage B according to the Barcelona Clinic Liver Cancer Staging System, who have no contraindication for TACE or who do respond to TACE therapy.
- •3) History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiering anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
- •4) Large oesophageal varices (>5 mm diameter) without prophylactic band ligation
- •5) History of HIV infection
- •6) Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
- •7) Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •8) History of organ allograft. The organ allograft may be allowed as protocol specific.
- •9) Patients undergoing renal dialysis
- •10) Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
- •11) Patients unable to swallow oral medication
- •12) Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
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