Inclusion criteria | Exclusion criteria |
---|---|
• Men and women >18 years of age | • Prior systemic anticancer therapy or local tumor therapy (i.e. LITT; PEI, cryotherapy, RFA, TACE) |
• HCC (single nodule -8 cm or max. 3 nodules ≤3 cm) diagnosed by histology or non-invasive EASL criteria | • Significant cardiovascular disease such as myocardial infarction < 6 months previously, chronic heart failure (revised NYHA grade III-IV) or unstable coronary artery disease |
• Baseline CT or MRI and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease | • Extrahepatic disease, portal vein or other major vascular involvement; |
• Hb >9.0 g/%, WBC >3.000 cells/mm3 (ANC >1.500 cells/mm3), platelets >75.000 cells/mm3, bilirubin <3 mg/dl | • Uncontrolled hypertension despite optimal management |
• Karnofsky index >70% | • Thrombotic or embolic events including transient ischemic attacks within the past 6 months |
• Bilateral renal function with serum creatinine <1.5 mg/dl | • Hemorrhage/bleeding event = Grade 3 within 4 weeks of first dose of study drug |
• INR/PTT < 1,5 × upper limit of normal | • Patients with previous malignancy other than carcinoma in situ of the skin and the cervix within the past 5 years prior to treatment |
• Written informed consent | • Pregnant or breastfeeding patients. |
• Patients with uncontrolled infections or HIV seropositive patients | |
• Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study. No patient will be enrolled in this study more than once | |
• Prior organ transplant (e.g. renal Tx) | |
• Concomitant immunosuppressive treatment (before LTx) | |
• Patients not eligible for LTx. Severe pulmonary disease that would be hazardous for LTx |