EUCTR2008-008232-87-DE进行中（未招募）不适用
Open-label phase II study of sorafenib in patients with advanced hepatocellular carcinoma (HCC) and Child Pugh score B with special analysis of patients 65 years or older - Sorafenib in Child Pugh Score B patients
Charite Universitätsmedizin Berlin- Campus Virchow-Klinikum0 个研究点开始时间: 2009年3月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Subjects with proven HCC not suitable for loco-regional treatment options, resection or liver transplantation. Diagnosis of HCC can be made either histologically or according to EASL criteria.
- •2.Child-Pugh stage B
- •3.Age > 18 years
- •4.ECOG Performance Status of 0 to 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 MRI or CT
- •7.Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •- Hemoglobin > 9.0 g/dl
- •- Absolute neutrophil count (ANC) >1,500/mm3
- •- Platelet count ? 50,000/µl
- •- Total bilirubin < 3 times the upper limit of normal
- •- ALT and AST < 5 x upper limit of normal
- •- Alkaline phosphatase < 4 x upper limit of normal
- •- PT-INR/PTT < 1.5 x upper limit of normal
- •- Serum creatinine < 1.5 x upper limit of normal, creatinine clearance > 60 ml/min
- •8. Signed and dated informed consent before the start of specific protocol procedures
- •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
- •Excluded medical conditions:
- •1.Child-Pugh stages A and C
- •2.Patients eligible for loco-regional treatment options, resection or transplantation
- •3.Patients with portal vein thrombosis exceeding thrombosis of a single intrahepatic branch
- •4.Patients with esophageal varices grade II (with high risk signs) or grade III without prior prophylactic band ligation
- •5.Acute variceal bleeding within the last 4 weeks
- •6.Ascites not adequately controlled by diuretic therapy
- •7.Encephalopathy > grade I
- •8.Uncontrolled arterial hypertension with systolic blood pressure >160 mmHg or diastolic blood pressure > 90 mm Hg despite optimal treatment
- •9.History of cardiac disease:
- •a)congestive heart failure > NYHA class 2;
- •b)active CAD (MI more than 6 mo prior to study entry is allowed);
- •c) cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), or
- •d)uncontrolled hypertension (defined as blood pressure = 160 mmHg systolic and/or = 90 mmHg diastolic on medication)
- •10.History of HIV infection
- •11.Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •12.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)
- •13.Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •14.History of organ allograft.
- •15.Patients with evidence or history of bleeding diathesis
- •16.Serious non-healing wound, fracture, or ulcer
- •17.Major surgery within the last 4 weeks
- •18.Thrombotic or embolic events within the last 6 months
- •19.Patients undergoing renal dialysis
- •20.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.
- •21.Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. 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).
- •22.Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •23.Known severe hypersensitivity to sorafenib or any of the excipients
- •24.Patients unable to swallow oral medications.
- •25.Participation in another clinical study within 30 days of enrollment
- •26.Patients unable to give written informed consent
- •27.Patients that are placed in institutions by the order of a judge or other regulatory authority.
- •Excluded therapies and medications, previous and concomitant:
- •1.Anticancer chemotherapy or immunotherapy or targeted therapy (except study medication) during the study or within 4 weeks of study entry.
- •2.Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
- •3.Major surgery within 4 weeks of start of study
- •4.Autologous bone marrow transplant or stem cell rescue within 4 months of study
- •5.Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity suc
研究者
相似试验
进行中（未招募）
1 期
An exploratory study of sorafenib for patients listed for transplantation due to HCCPatients >18 years with hepatocellular carcinoma, on waiting list for liver transplantationMedDRA version: 12.1Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentMedDRA version: 12.1Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectableEUCTR2010-024306-36-SEVästra Götalandsregionen21
进行中（未招募）
1 期
A randomized phase II trial assessing Sorafenib (Nexavar®) in combination with irinotecan in metastatic colorectal cancer patients with KRAS mutated tumours after failure of all active drugs known to be effective. - NEXIRI 2metastatic colorectal cancerMedDRA version: 16.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864EUCTR2012-000644-94-FRCentre Val d’Aurelle - Paul Lamarque159
进行中（未招募）
1 期
A Phase 2 study of Sorafenib (BAY 43-9006) in patients with advanced salivary Adenoid Cystic CarcinomaEUCTR2008-000066-22-GBChristie Hospital NHS Foundation Trust
已完成
2 期
Sorafenib in BAC or Never-Smokers With Lung AdenocarcinomaLung CancerNCT00456716Swedish Medical Center5
已完成
2 期
Phase II study of sorafenib in patients with advanced hepatocellular carcinomaHepatocellular carcinomaJPRN-UMIN000002972Kyorin University Hospital80