EUCTR2011-001690-62-GB进行中（未招募）1 期
A randomised phase II clinical trial of conditioning cyclophosphamide and chemoembolisation with or without vaccination with dendritic cells pulsed with HepG2 lysate ex vivo in patients with Hepatocellular Carcinoma - IMMUNOTACE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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.Histological or cytological diagnosis or meet the AASLD criteria for
- •diagnosis of HCC and at least one uni-dimensional lesion measurable
- •according to the RECIST 1.1 criteria by CT-scan or MRI.
- •2.Suitable for TACE
- •3.Aged = 18 years and estimated life expectancy = 6 months
- •4.Not a candidate for surgical resection or transplantation
- •5.No previous chemotherapy, radiotherapy, immunotherapy or other experimental
- •treatment for HCC prior to entry into the trial
- •6.ECOG performance status = 2
- •7.Adequate haematological function: Hb = 90g/L, Absolute neutrophil count
- •= 1.5x109/L, platelet count = 50x10^9/L
- •8.Bilirubin = 50 µmol/L, AST or ALT = 5 x ULN
- •9.Adequate renal function: Cockroft and Gault estimation = 40ml/min
- •10.INR = 1.5
- •11.Child-Pugh score = 7
- •12.Women of child-bearing potential should have a negative pregnancy test prior
- •to trial entry
- •13.Women of child-bearing potential and men who have partners of child-bearing
- •potential must be willing to practise effective contraception for the
- •duration of the study and for three months after the completion of
- •14.Written informed consent
- •15. Suitable veins for access with 17G fistula needle
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 41
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1.Extra-hepatic metastasis
- •2.Prior embolisation, systemic or radiation therapy for HCC
- •3.Investigational therapy or major surgery within 4 weeks of trial entry
- •4.Any ablative therapy (RFA or PEI) for HCC (this should not exclude patients
- •if target lesion(s) have not been treated and occurred >6 weeks prior trial
- •5.Child Pugh score >7
- •6.Hepatic encephalopathy
- •7.Ascites refractory to diuretic therapy
- •8.Documented invasion of the main portal vein
- •9.Hypersensitivity to intravenous contrast agents
- •10.Active clinically serious infection > grade 2 CTCAE version 4 within
- •preceding 2 weeks
- •11.Pregnant or lactating women
- •12.History of second malignancy except those treated with curative intent more
- •than three years previously without relapse and non-melanotic skin cancer or
- •cervical carcinoma in situ
- •13.Evidence of severe or uncontrolled systemic diseases, congestive cardiac
- •failure > NYHA class 2, Myocardial Infection within 6 months or laboratory
- •finding that in the view of the investigator makes it undesirable for the
- •patient to participate in the trial
- •14.Psychiatric or other disorder likely to impact on informed consent
- •15.Known history of HIV
- •16.Patient is unable and/or unwilling to comply with treatment and trial
- •instructions
- •17.Patients with active auto-immune disorder
- •18. Hypersensitivity to cyclophosphamide or to any of its metabolites
- •19. Current cystitis infection
- •20. Urinary outflow obstruction
研究者
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