EUCTR2007-000730-40-DE进行中（未招募）不适用
Phase II study evaluating transarterial chemoembolization (TACE) in combination with sorafenib for the treatment of advanced hepatocellular carcinoma (HCC) - TACE and sorafenib for HCC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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 histologically confirmed HCC not suitable for resection or liver transplantation (> 3 tumors > 3 cm; one tumor > 5 cm; vascular invasion; corresponding to intermediate stage according to the BCLC staging criteria)
- •– Age >= 18 years
- •–Patients with measurable disease according to RECIST
- •– Performance status ECOG 0-2
- •– Patients naive to treatment with respect to the HCC
- •– Normal organ and bone marrow function defined as:
- •– Hematopoetic: absolute neutrophil count > 1,500/mm3, platelet count > 100,000/mm3, hemoglobin > 9g/dL
- •– INR < 1.5 ULN and PTT within normal limits
- •– Hepatic: AST or ALT < 5 x ULN, alkaline phosphatase < 4 x ULN
- •– Renal: serum creatinine < 1.5 x ULN
- •– Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- •– Male or female patients with reproductive potential must use an approved contraceptive method during and for 3 months after the end of treatment with study medication (Approved methods for women are oral contraceptives with estrogen and progesterone, vaginal rings, contraceptive patches, estrogen-free ovulation inhibitors, intrauterine devices with progesterone, 3-month injections with depot progesterone, implants settting free progesterone, abstinence or sterilization (vasectomy) of the male partner. Men must use condomes.)
- •– Written informed consent (including consent to data reporting)
- •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
- •– Patient is eligible for liver resection or liver transplantation
- •– Extrahepatic tumor manifestation
- •– Thrombosis of the portal vein
- •– > 8 points according to Child Pugh classification
- •– Prior TACE or RFTA or any other local ablative treatment
- •– Prior systemic anticancer chemotherapy or radiotherapy for HCC
- •– Total bilirubin > 4.5 mg/dl
- •– Life expectancy of less than 12 weeks
- •– Esophageal varices grade III (any) or esophageal varices grade II with increased risk for bleeding (red wale signs, cherry spots, red coloration, hematocystic spots) without prophylactic band ligation
- •– Cardiac disease: congestive heart failure > class II NYHA, unstable angina or new onset of angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy
- •– Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal management
- •– Known or suspected hyperthyroid state
- •– Known brain metastasis. Patients with symptoms should undergo CT/MRT of the brain to exclude brain metastasis
- •– Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
- •– History of organ allograft
- •– Active clinically serious infections > CTCAE grade 2
- •– Thrombotic or embolic events including transient ischemic attacks within the past 6 months
- •– Hemorrhage/bleeding event >= CTCAE grade 3 within 4 weeks of first dose of study drug
- •– Acute variceal bleeding within the last 2 weeks
- •– Serious non healing wound, ulcer or bone fracture
- •– Evidence or history of bleeding diathesis or coagulopathy
- •– Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin is permitted if INR is < 1.5. Low dose aspirin is permitted (<= 100 mg/day)
- •– Chronic daily treatment with aspirin > 100 mg/day
- •– Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
- •– Known or suspected allergies to sorafenib, anthracyclines (including doxorubicin) or lipiodol (containing esters of iodinated fatty acids of poppy oil) or any agent given in the course of this trial
- •– Contraindications to the use of sorafenib, doxorubicin or lipiodol as mentioned in the current summary of product characteristics
- •– Previous cancer that is distinct in primary site or histology from HCC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry
- •– Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study
- •– Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment
- •– Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)
- •– Lactating women
研究者
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