ISRCTN93375053已完成3 期
TACE-2: a randomised placebo-controlled, double blinded, phase III trial evaluating sorafenib in combination with transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma (HCC)
niversity College London (UCL) (UK)0 个研究点目标入组 313 人开始时间: 2010年6月18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
- 313
研究概览
简要总结
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28648803 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histological or cytological diagnosis or meet the American Association for the Study of Liver Diseases (AASLD) criteria for diagnosis of HCC and at least one uni-dimensional lesion measurable according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- •2. Not a candidate for surgical resection
- •3. Aged greater than or equal to 18 years and estimated life expectancy greater than 3 months
- •4. Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 1
- •5. Adequate haematological function Hb greater than or equal to 9 g/L, absolute neutrophil count greater than or equal to 1.5 x 10^9/L, platelet count greater than or equal to 60 x 10^9/L
- •6. Bilirubin greater than or equal to 50 µmol/L, asparate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 5 x upper limit of normal (ULN), alkaline phosphatase (ALP) less than 4 x ULN
- •7. Adequate renal function; creatinine less than or equal to 1.5 x ULN
- •8. International normalised ratio (INR) greater than or equal to 1.5
- •9. Amylase and lipase less than 2 x ULN
- •10. Child-Pugh A (score less than or equal to 6)
- •11. Left ventricular ejection fraction greater than or equal to 45%
- •12. Women of child-bearing potential should have a negative pregnancy test prior to study entry. Both men and women must be using an adequate contraception method, which must be continued for 3 months after completion of treatment.
- •13. Written informed consent
- •14. Male and female, lower age limit of 18 years
排除标准
- •1. Extrahepatic metastasis
- •2. Prior embolisation, systemic or radiation therapy for HCC
- •3. Any contraindications for hepatic embolisation procedures procedures including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis
- •4. Investigational therapy or major surgery within 4 weeks of trial entry
- •5. Any ablative therapy (radiofrequency ablation [RFA] or percutaneous ethanol injection [PEI]) for HCC (this should not exclude patients if target lesion(s) have not been treated and occurred greater than 6 weeks prior study entry)
- •6. History of bleeding within the past 4 weeks
- •7. Child-Pugh cirrhosis C or B (score greater than or equal to 7)
- •8. Hepatic encephalopathy
- •9. Ascites refractory to diuretic therapy
- •10. Documented occlusion of the hepatic artery or main portal vein
- •11. Hypersensitivity to intravenous contrast agents
- •12. Active clinically serious infection greater than grade 2 National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0
- •13. Pregnant or lactating women
- •14. Known history of human immunodeficiency virus (HIV) infection
- •15. History of second malignancy except those treated with curative intent more than three years preciously without relapse and non-melanotic skin cancer or cervical carcinoma in situ
- •16. Evidence of severe or uncontrolled systemic diseases, cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), uncontrolled hypertension, congestive cardiac failure greater than New York Heart Association (NYHA) class 2, myocardial infarction (MI) within 6 months or laboratory finding that in the view of the Investigator makes it undesirable for the patient to participate in the trial
- •17. Psychiatric or other disorder likely to impact on informed consent
- •18. Patient is unable and/or unwilling to comply with treatment and study instructions
- •19. Patient unable to swallow oral medications
研究者
相似试验
已完成
2 期
A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic GastroparesisIdiopathic GastroparesisDiabetic GastroparesisNCT03544229Millennium Pharmaceuticals, Inc.242
已完成
2 期
Cisplatin Ototoxicity attenuated by ASpirin Trial (COAST)CancerISRCTN83689269Southampton University Hospitals NHS Trust (UK)88
终止
2 期
Study of TAC-101 as Second Line Treatment in Patients With Advanced Hepatocellular Carcinoma Who Received Sorafenib as First Line TherapyHepatocellular CarcinomaNCT00687596Taiho Oncology, Inc.52
终止
2 期
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)Primary Biliary Cirrhosis (PBC)NCT02609048Gilead Sciences41
已完成
不适用
Studying the impact of Doxycycline on fear memory in healthy individualsISRCTN66987216Psychiatric University Hospital (Psychiatrische Universitätsklinik) Zürich (PUK ZH)160