C22.0
Conditions
Interventions
Group 1: TACE ( transarterial chemoembolisation) + intermittent Sorafenib-therapy (for 7 days, starting with TACE-treatment)
Group 2: TACE treatment
Sponsors
Dekanat des Fachbereichs Medizin Klinikum der Johann Wolfgang Goethe-Universität, Haus 1
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written informed consent granted prior to initiation of any study specific screening procedures – Patients with histologically confirmed HCC not suitable for resection or liver transplantation (> 3 tumors > 3 cm; one tumor > 5 cm). Vascular invasion is allowed as long as the main trunk of the portal vein is not invaded) – Absence of extrahepatic spread – Age > 18 years – Patients with measurable disease according to RECIST – Performance status ECOG 0 and 1 (Appendix 20) – Patients naive to treatment with respect to the HCC – Normal organ and bone marrow function defined as: – Hematopoetic: absolute neutrophil count > 1,500/mm3, platelet count > 60,000/mm3, hemoglobin > 9g/dL – INR < 1.5 ULN – Hepatic: AST or ALT < 5 x ULN, bilirubin = 3 mg/dl – Renal: serum creatinine < 1.5 x ULN – Child-Pugh stage A – Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the randomization – Male or female patients of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received
Exclusion criteria
Exclusion criteria: Extrahepatic tumor manifestation – Thrombosis of the main portal vein (thrombosis of a side-branch is allowed) – Child Pugh status B or C > 6 points according to Child Pugh classification – Prior TACE or selective intraarterial Radiotherapiy (SIRT) – Prior systemic anticancer chemotherapy for HCC – Life expectancy of less than 12 weeks – 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 – Cardiac disease: congestive heart failure > class II NYHA, unstable angina or new onset of angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy – Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal management – Known or suspected hyperthyroid state – Known brain metastasis. Patients with symptoms should undergo CT/MRT of the brain to exclude brain metastasis – Patients with seizure disorder requiring medication (such as steroids or antiepileptics) – History of organ allograft – Active clinically serious infections > CTCAE grade 2 except chronic hepatitis C infection – Thrombotic or embolic events including transient ischemic attacks within the past 6 months – Hemorrhage or bleeding event, CTCAE grade 3 within 4 weeks of first dose of study drug – Acute variceal bleeding within the last 2 weeks – Serious non healing wound, ulcer or bone fracture – Evidence or history of bleeding diathesis or coagulopathy – Therapeutic anticoagulation with Marcumar, heparins or indirect factor-Xa inhibitors or direct thrombinantagonists. Low dose aspirin is permitted (100 mg per day) – Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug – Known or suspected allergies to sorafenib, mitomycin C or lipiodol – 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 – Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study – Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment – Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator) – Pregnancy and breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| determination of time to progression (TTP) by mRECIST for HCC | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of – overall survival (OS) – response rate (either complete response, CR, or partial response, as measured by mRECIST for HCC) – safety profile – quality of life (as measured by FACT-Hep and EQ-5D questionaires | — |
Countries
Germany
Contacts
Public ContactJörg Trojan
Universitätsklinikum Frankfurt Medizinische Klinik 1
Outcome results
None listed