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临床试验/DRKS00012551
DRKS00012551已完成2 期

Intermittent treatment with sorafenib in combination with transarterial chemoembolization (TACE) in hepatocellular carcinoma (HCC): a randomized open-label phase 2 study - INTERSORTACE

Dekanat des Fachbereichs Medizin Klinikum der Johann Wolfgang Goethe-Universität, Haus 10 个研究点目标入组 54 人开始时间: 2017年7月12日最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
54
研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

see attached CSR

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one（—）
性别
All

入选标准

  • •Written informed consent granted prior to initiation of any study specific screening procedures
  • •– Patients with histologically confirmed HCC not suitable for resection or liver transplantation (> 3 tumors > 3 cm; one tumor > 5 cm). Vascular invasion is allowed as long as the main trunk of the portal vein is not invaded)
  • •– Absence of extrahepatic spread
  • •– Age > 18 years
  • •– Patients with measurable disease according to RECIST
  • •– Performance status ECOG 0 and 1 (Appendix 20)
  • •– 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 > 60,000/mm3, hemoglobin > 9g/dL
  • •– INR < 1.5 ULN
  • •– Hepatic: AST or ALT < 5 x ULN, bilirubin = 3 mg/dl
  • •– Renal: serum creatinine < 1.5 x ULN
  • •– Child-Pugh stage A
  • •– Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the randomization
  • •– Male or female patients of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received

排除标准

  • •Extrahepatic tumor manifestation
  • •– Thrombosis of the main portal vein (thrombosis of a side-branch is allowed)
  • •– Child Pugh status B or C > 6 points according to Child Pugh classification
  • •– Prior TACE or selective intraarterial Radiotherapiy (SIRT)
  • •– Prior systemic anticancer chemotherapy for HCC
  • •– 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 except chronic hepatitis C infection
  • •– Thrombotic or embolic events including transient ischemic attacks within the past 6 months
  • •– Hemorrhage or 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 Marcumar, heparins or indirect factor-Xa inhibitors or direct thrombinantagonists. Low dose aspirin is permitted (100 mg per day)
  • •– Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
  • •– Known or suspected allergies to sorafenib, mitomycin C or lipiodol
  • •– 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)
  • •– Pregnancy and breast-feeding women

研究者

发起方
Dekanat des Fachbereichs Medizin Klinikum der Johann Wolfgang Goethe-Universität, Haus 1

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