EUCTR2008-002269-29-DE进行中（未招募）1 期
A prospective, randomized, double-blind, multicenter, Phase III clinical study on transarterial chemoembolisation (TACE) combined with Sorafenib vs. TACE plus placebo in patients with hepatocellular cancer (HCC) before liver transplantation (LTx) – Heidelberg Liver Cancer Study [HEILIVCA STUDY] - HeiLivCa
niversitätsklinikum Heidelberg0 个研究点目标入组 192 人开始时间: 2009年1月27日最近更新:
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
- 192
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 hepatocellular carcinoma (HCC) without extrahepatic disease.
- •Inclusion Criteria
- •Patients with HCC without prior therapy, basically eligible for LTx at screening
- •HCC diagnosed by histology or per non-invasive European Association for the Study of the Liver (EASL) criteria (only cirrhotic patients):
- •1. Radiological criteria: two coincident imaging techniques: Focal lesion > 2 cm with arterial hypervascularization
- •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 and bone scan without evidence of radiographically definable vascular invasion or extrahepatic disease not older than 28 days, for bone scans not older than 8 weeks
- •Sufficient hematologic, liver and renal function: Hb>9.0g/%, WBC >3.000cells/mm³ (ANC>1.500cells/mm³), platelets >75.000 cells/mm³, Bilirubin <3mg/dl. Patients should have bilateral renal function, as determined by abdominal CT with serum creatinine <1.5mg/dl and Creatinine clearance (CrCL) >30ml/min in 24h urine or Modification of Diet in Renal Disease Rate (MDRD)
- •PT-INR/PTT <1.5x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists].
- •Performance status: Karnofsky index >70%
- •No acute infections at the time of therapy initiation
- •Patients must sign a study specific informed consent form
- •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
- •Residual radiological definable extrahepatic disease, portal vein involvement or lymph node involvement in CT, MRI or bone scan. Patients who are not potentially eligible for LTx are excluded.
- •Patients with prior or concomitant systemic anticancer therapy or local tumor therapy (i.e. LITT; PEI, cryotherapy, RFA), or with prior TACE <= 3 days before randomisation or with concomitant biologic-response modifiers, strong CYP3A4 inhibitors
- •Patients with significant cardiovascular disease such as myocardial infarction <6months previously, chronic heart failure (revised New York Hearth Association (NYHA) grade III-IV) or unstable coronary artery disease
- •Patients with severe pulmonary disease that would be hazardous for LTx
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure >90 mm Hg, despite optimal management
- •Thrombotic or embolic events including transient ischemic attacks within the past 6 months
- •Hemorrhage/bleeding event =Grade 3 within 4 weeks of first dose of study drug
- •Patients with contraindication to arterial procedure during TACE (portal or liver vein infiltration, allergy against contrast dye, uncontrolled hyperthyroidism)
- •Patients with previous malignancy other than carcinoma in situ of the skin and the cervix within 5 years prior treatment
- •Patients < 18 years
- •Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication). Women of childbearing potential must agree to practice adequate contraception and to refrain from breastfeeding, as specified in the informed consent.
- •Patients with uncontrolled infections or HIV sero-positive patients
- •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- •Mental conditions rendering the 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 (e.g. renal…)
- •Concomitant immunosuppressive treatment (steroids, mycophenolate mofetil, cyclosporine, temsirolimus, everolimus, tacrolimus, …)
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