ImmunoTACE
- Conditions
- Hepacellular CarcinomaCancerLiver
- Registration Number
- ISRCTN11889464
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 48
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free survival time at every visit
- Secondary Outcome Measures
Name Time Method