Hepacellular Carcinoma Cancer Liver
Conditions
Interventions
Dendritic cell vaccine, Cyclophosphamide, TACE (standard treatment)
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 9g/L, Absolute neutrophil count >1.5x109/L, platelet count >50x109/L 8. Bilirubin 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 9g/L, Absolute neutrophil count >1.5x109/L, platelet count >50x109/L 8. Bilirubin 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free survival time at every visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 12/02/2019: 1. Radiological response assessment (RECIST 1.1 criteria) measured at baseline, Day 60 and then every 3 months thereafter 2. Change in the tumour marker serum alpha-fetoprotein (AFP) at every visit 3. Assessment of toxicity using Common Terminology Criteria for Adverse Events (CTCAE) (version 4) at every visit 4. Immune response at every visit 5. Overall survival time 6. Radiological response based on modified RECISIT (mRECIST) 7. Progression free survival at 12 months where progression is determined by mRECIST Previous secondary outcome measures: 1. Radiological response rate (RECIST criterion) measured at baseline, Day 60 and then every 3 months thereafter 2. Rate of change in the tumour marker serum alpha-fetoprotein (AFP) at every visit 3. Assessment of toxicity using National Cancer Institute ? common terminology criteria for adverse events version 4.02 (NCI-CTCAE version 4) at every visit 4. Immune response rate at every visit 5. Overall survival | — |
Countries
United Kingdom
Outcome results
None listed