Patients with Hepatocellular carcinoma not amenable to curative treatment MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10007416 Term: Carcinoma liver System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA
Conditions
Interventions
Product Name: Irinotecan
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IRINOTECAN
CAS Number: 97682-44-5
Product Name: Mitomycin C
Pharmaceutical Form: Solution for infusion
INN or
Sponsors
Goethe-Universität Frankfurt
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent granted prior to initiation of any study specific screening procedures 2. Patients with histologically confirmed HCC primarily not suitable for resection, ablation or liver transplantation. A combined therapy with TACE and subsequent ablation is possible. 3. Availability of Biopsy for translational research, if patients give their consent 4. Absence of extrahepatic spread 5. Age >/= 18 years 6. Patients with measurable disease according to mRECIST 7. Performance status ECOG 0 and 1 (Appendix 20) 8. Normal organ and bone marrow function defined as: – Hematopoetic: absolute neutrophil count = 1,500/mm3, platelet count = 60 x 109/l, hemoglobin = 9 g/dL – INR = 1.5 x ULN – Hepatic: AST and ALT =65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
Exclusion criteria: 1. Extrahepatic tumor manifestation 2. Tumor infiltration of more than 50% of the whole liver mass 3. Infiltration or thrombosis of the main portal vein or the main left or right intrahepatic branches 4. Child Pugh status B or C > 6 points according to Child Pugh classification (Appendix 20) 5. Prior TACE or selective intraarterial Radiotherapy (SIRT) 6. Prior systemic anticancer therapy for HCC 7. Life expectancy of less than 12 weeks 8. Esophageal varices grade III (any) or esophageal varices grade II with increased risk for bleeding (red wale signs, cherry spots, red coloration, hematocystic spots) without prophylactic band ligation 9. Known or suspected manifest hyperthyroidism 10. Congestive heart failure > class II NYHA (Appendix 20) 11. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy, acute myocardial infarction, myocardial infarction, acute inflammatory heart disease > CTCAE grade 2 within the past 6 months (Appendix 20) 12. Previous treatment with doxorubicin up to the maximum lifetime dose of 550mg/m2 13. History of organ allograft or bone marrow transplantation 14. Active uncontrolled clinically serious infections > CTCAE grade 2 except chronic hepatitis C infection (Appendix 20) 15. Severe restrictive or obstructive lung disease 16. Clinically apparent chronic inflammatory bowel disease and/or ileus 17. Hemorrhage/bleeding event or variceal bleeding > CTCAE grade 2 within 4 weeks of first dose of study drug (Appendix 20) 18. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug 19. Known or suspected allergies to Iodine-containing or Gadolinum-containing contrast medium, Irinotecan, Mitomycin C, Doxorubicin or other inactive ingredients of the drugs 20. Previous cancer that is distinct in primary site or histology from HCC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry 21. Concomitant treatment with St. John's wort 22. Substance abuse, medical, psychological or social condition that may interfere with the patient´s participation in the study 23. Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment 24. Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator) 25. Pregnancy or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the progression free survival (PFS) time;Secondary Objective: Determination of – overall survival (OS) – response/disease control rate (DCR) (either complete response, CR, or partial response, as measured by mRECIST for HCC) – time to progression – time to macrovascular invasion/extrahepatic spread (MVI/EHS) – time to unTACEable progression – safety profile – quality of life (as measured by FACT-Hep and FACT-G7 questionnaires) ;Primary end point(s): Progression free survival (PFS) time;Timepoint(s) of evaluation of this end point: continuously | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): – overall survival (OS) – response/disease control rate (DCR) (either complete response, CR, or partial response, as measured by mRECIST for HCC) – time to progression – time to macrovascular invasion/extrahepatic spread (MVI/EHS) – time to unTACEable progression – safety profile – quality of life (as measured by FACT-Hep and FACT-G7 questionnaires);Timepoint(s) of evaluation of this end point: continuously | — |
Countries
Germany
Contacts
Public ContactProject Management
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Outcome results
None listed