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Table 1 Criteria for inclusion and exclusion of patients

From: Prospective, randomized, double-blind, multi-center, Phase III clinical study on transarterial chemoembolization (TACE) combined with Sorafenib®versus TACE plus placebo in patients with hepatocellular cancer before liver transplantation – HeiLivCa [ISRCTN24081794]

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