Transarterial chemoembolization (TACE) with Irinotecan and Mitomycin C versus TACE with Doxorubicin in patients with Hepatocellular carcinoma not amenable to curative treatment - IRITACE- a randomized multicenter phase 2 trial. A trial of the German Alliance for Liver Cancer (GALC)
- Conditions
- C22Malignant neoplasm of liver and intrahepatic bile ducts
- Registration Number
- DRKS00017416
- Lead Sponsor
- Dekanat des Fachbereichs Medizin Klinikum der Johann Wolfgang Goethe-Universität, Haus 1
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 20
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 < 5 x ULN, bilirubin = 2 mg/dl
– Renal: serum creatinine = 1.5 x ULN
9. Child-Pugh stage A
10. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolment
11. Male or female patients of child-bearing potential must agree to use oral contraception, intrauterine device, bilateral tubal occlusion, vasectomized partner or avoidance of intercourse during the study and for 180 days after last investigational drug dose received
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) time
- Secondary Outcome Measures
Name Time Method overall survival (OS);<br>response/disease control rate (DCR) (either complete response, CR, or partial response, as measured by mRECIST for HCC);<br>time to progression;<br>time to macrovascular invasion/extrahepatic spread (MVI/EHS);<br>time to unTACEable progression;<br>safety profile;<br>quality of life (as measured by FACT-Hep and FACT-G7 questionnaires)