ISRCTN24081794已完成3 期
A prospective, randomised, double-blind, multicentre, phase III clinical study on transarterial chemoembolisation (TACE) combined with sorafenib versus TACE plus placebo in patients with hepatocellular cancer (HCC) before liver transplantation (LTx) -Heidelberg Liver Cancer Study (HeiLivCa Study)
niversity of Heidelberg (Germany)0 个研究点目标入组 204 人开始时间: 2008年5月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Both male and female patients
- •2. Patients with HCC without extrahepatic disease
- •3. Patients with HCC without prior systemic therapy, basically eligible for liver transplantation (LTx) at screening
- •4. HCC diagnosed by histology or per non-invasive European Association for the Study of the Liver (EASL) criteria (only cirrhotic patients):
- •4.1. Radiological criteria: two coincident imaging techniques: focal lesion greater than 2 cm with arterial hypervascularisation
- •4.2. Combined criteria: one imaging technique associated with alpha-fetoprotein (AFP): focal lesion greater than 2 cm with arterial hypervascularisation and AFP levels greater than 400 ng/ml
- •5. Pretreatment computed tomography (CT) or magnetic resonance imaging (MRI) and bone scan without evidence of radiographically definable vascular invasion or extrahepatic disease not older than 28 days
- •6. Sufficient haematologic, liver and renal function: Hb greater than 9.0 g/%, white blood cell (WBC) count greater than 3,000 cells/mm^3 (absolute neutrophil count [ANC] greater than 1.500 cells/mm^3), platelets greater than 75,000 cells/mm^3, bilirubin less than 3 mg/dl. Patients should have bilateral renal function, as determined by abdominal CT with serum creatinine less than 1.5 mg/dl and creatinine clearance (CrCL) greater than 30 ml/min in 24 h urine or Modification of Diet in Renal Disease Rate (MDRD).
- •7. Prothrombin time International Normalised Ratio (PT-INR)/activated partial thromboplastin time (PTT) less than 1.5 x 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)
- •8. Performance status: Karnofsky index greater than 70%
- •9. No acute infections at the time of therapy initiation
- •10. Staging studies completed within 3 weeks of protocol registration
- •11. Patients must sign a study specific informed consent form
排除标准
- •1. 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
- •2. Patients with prior or concomitant systemic anticancer therapy or local tumour therapy (i.e. laser-induced interstitial thermotherapy [LITT]; percutaneous ethanol injection [PEI], cryotherapy, radiofrequency ablation [RFA]), or with prior TACE or with concomitant biologic-response modifiers, strong CYP3A4 inhibitors
- •3. Patients with significant cardiovascular disease such as myocardial infarction <6 months previously, chronic heart failure (revised New York Hearth Association [NYHA] grade III-IV) or unstable coronary artery disease
- •4. Patients with severe pulmonary disease that would be hazardous for LTx
- •5. Uncontrolled hypertension defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg, despite optimal management
- •6. Thrombotic or embolic events including transient ischaemic attacks within the past 6 months
- •7. Haemorrhage/bleeding event greater than or equal to Grade 3 within 4 weeks of first dose of study drug
- •8. Patients with contraindication to arterial procedure during TACE (portal or liver vein infiltration, allergy against contrast dye, uncontrolled hyperthyroidism)
- •9. Patients with previous malignancy other than carcinoma in situ of the skin and the cervix within 5 years prior treatment
- •10. Patients less than 18 years
- •11. 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
- •12. Patients with uncontrolled infections or HIV sero-positive patients
- •13. Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study
- •14. 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
- •15. No patient will be allowed to enrol in this study more than once
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