ISRCTN11889464进行中（未招募）2 期
A randomised phase II clinical trial of conditioning cyclophosphamide and chemoembolisation with or without vaccination with dendritic cells pulsed with hepg2 lysate in vivo in patients with hepatocellular carcinoma (HCC)
niversity of Birmingham (UK)0 个研究点目标入组 48 人开始时间: 2013年12月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 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
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria:
- •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 unidimensional lesion measurable according to the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) by CT-scan or MRI
- •2. Suitable for transcatheter arterial chemoembolization (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 >9g/L, Absolute neutrophil count >1.5x109/L, platelet count >50x109/L
- •8. Bilirubin < 50 umol/L , AST or ALT < 5 x ULN
- •9. Adequate renal function: Cockroft and Gault estimation > 40ml/min
- •10. INR less than or equal to 1.5
- •11. ChildPugh score = 7
- •12. Women of childbearing potential should have a negative pregnancy test prior to trial entry
- •13. Women of childbearing potential and men who have partners of childbearing potential must be willing to practise effective contraception for the duration of the study and for six months after the completion of treatment.
- •14. Written informed consent
- •15. Suitable veins for access with 17G fistula needle
- •Previous participant inclusion criteria:
- •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 unidimensional lesion measurable according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria by CT scan or MRI
- •2. Suitable for transcatheter arterial chemoembolization (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 >9g/L, Absolute neutrophil count >1.5x109/L, platelet count >50x109/L
- •8. Bilirubin < 50 umol/L , AST or ALT < 5 x ULN
- •9. Adequate renal function: Cockroft and Gault estimation > 40ml/min
- •10. INR less than or equal to 1.5
- •11. ChildPugh score < 7
- •12. Women of childbearing potential should have a negative pregnancy test prior to trial entry
- •13. Women of childbearing potential and men who have partners of childbearing potential must be willing to practise effective contraception for the duration of the study and for three months after the completion of treatment.
- •14. Written informed consent
排除标准
- •Current participant exclusion criteria as of 12/02/2019:
- •1. Extrahepatic 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 [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 >6 weeks prior trial entry]
- •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 NCI-CTC version 4.0 within preceding two 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 nonmelanotic skin cancer or cervical carcinoma in situ
- •13. Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure >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
- •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 autoimmune disorder
- •18. Hypersensitivity to cyclophosphamide or to any of its metabolites
- •19. Current cystitis infection
- •20. Urinary outflow obstruction
- •Previous participant exclusion criteria:
- •1. Extrahepatic 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 [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 >6 weeks prior trial entry]
- •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 NCI-CTC version 4.0 (appendix 7) within preceding two 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 nonmelanotic skin cancer or cervical carcinoma in situ
- •13. Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure >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
- •14. Psychiatric or other disorder likely to impact on informed consent
- •15. Known history of HIV
- •16. Patient is unable
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