EUCTR2009-018058-44-FR进行中（未招募）不适用
Proof-of-concept phase II study to evaluate the anti-tumoractivity of sorafenib along with pathological and molecularchanges in tumor samples from patientswith resectable hepatocellular carcinoma. - BIOSHARE
GERCOR0 个研究点开始时间: 2010年3月18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.Signed and dated informed consent.
- •2.Histological proven diagnosis of HCC. Patients with fibrolamellar or mixed histology are eligible.
- •3.Patient eligible for conservative hepatic resection, liver resection, with curative intent.
- •4.No cirrhosis or cirrhosis status with Child-Pugh score = 7 (status A or B7).
- •5.Men or women of at least 18 years of age.
- •6.Body mass index between 18.5 and 30 kg/m2 (WHO normal range: 18.5 – 25).
- •7.Life expectancy = 3 months.
- •8.Performance status 0 to 1 (ECOG).
- •9.Ability to swallow oral compound.
- •10.Patients must have adequate organ function including :
- •-Haematologic: WBC > 3000, ANC > 1500, platelets = 100,000, haemoglobin = 9 g/dl.
- •-Hepatic: Bilirubin < 1.5 X upper normal limit (UNL), aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatise (AP) = 5 X UNL.
- •-Renal: Serum creatinine < 2 X UNL
- •-Prothrombin Time (PT) or international normalized ratio (INR) of PT, and partial thromboplastin time (PTT) < 1.5 X UNL; subjects receiving anti-coagulation therapy such as warfarin or heparin are allowed to participate if the coagulation parameters were within the above mentioned ranges prior to initiation of anticoagulant therapy.
- •-Amylase and lipase < 1.5 X UNL.
- •11.Chronic liver disease without liver insufficiency and without portal liver hypertension.
- •12.For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study drug.
- •13.Men and women are required to use adequate birth control during the study (when applicable).
- •14.Registration in a national health care system (CMU included).
- •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.Patient previous or candidate to orthotopic liver transplantation.
- •2.Any prior systemic or loco-regional treatment for HCC.
- •3.Cirrhotic status with Child-Pugh score > 7 (status B8-9 or C).
- •4.Any criterion for unresectability or medical condition that eventually contraindicates surgical resection at baseline evaluation.
- •5.Presence of any serious concomitant systemic disorders incompatible with the study, including uncontrolled hypertension, i.e. > 150/100 mmHg despite optimal therapy), or active uncontrolled infection, or active alcoholism.
- •6.Previous history of organ allograft or another malignancy (other than basal or squamous cell skin carcinoma or cured in situ cervical carcinoma) within 5 years of study entry.
- •7.Known history or presence of metastatic brain or meningeal tumors. Seizure disorder requiring medications such as anti-epileptics.
- •8.Concomitant treatment with full-dose anticoagulants (deep vein or catheter-associated thrombosis prophylaxis is permitted).
- •9.Cardiac arrhythmias requiring anti-arrhythmics (excluding beta-blockers or digoxin for chronic atrial fibrillation), active coronary artery disease or ischemia (myocardial infarction within the last 6 months), congestive heart failure > New York Heart Association (NYHA) Class II, pulmonary embolism or gastrointestinal bleeding during the 6 months prior to study entry.
- •10.Known history of human immunodeficiency virus (HIV) infection, or chronic hepatitis B or C.
- •11.Active clinically serious bacterial or fungal infections, i.e. grade 2 CTC [CTCAE] Version 3.
- •12.Any condition that is unstable or that could jeopardize the safety of the subject and his/her compliance with the study. Substance abuse or medical, psychological, or social conditions that could interfere with the subject’s adhesion to the study.
- •13.Known or suspected allergy to the investigational agent or to any agent given concomitantly.
- •14.Presence of asthenia or rash greater than CTC grade 1 at enrolment.
- •15.Treatment with any other investigational medicinal product within 28 days prior to study entry.
- •16.Chronic co-administration of CYP3A4 inducers such as rifampin, or millepertuis (hypericum perforatum), or phenytoin, or carbamazepine, or phenobarbital, or dexamethasone.
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