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]

The HeiLivCa study is a double-blinded, controlled, prospective, randomized multi-centre phase III trial. Patients in study arm A will be treated with transarterial chemoembolization plus sorafenib 400 mg bid. Patients in study arm B will be treated with transarterial chemoembolization plus placebo. A total of 208 patients with histologically confirmed hepatocellular carcinoma or HCC diagnosed according to EASL criteria will be enrolled. An interim patients' analysis will be performed after 60 events. Evaluation of time-to-progression as primary endpoint (TTP) will be performed at 120 events. Secondary endpoints are number of patients reaching LTx, disease control rates, OS, progression free survival, quality of live, toxicity and safety.As TACE is the most widely used primary treatment of HCC before LTx and sorafenib is the only proven effective systemic treatment for advanced HCC there is a strong rational to combine both treatment modalities. This study is designed to reveal potential superiority of the combined TACE plus sorafenib treatment over TACE alone and explore a new neo-adjuvant treatment concept in HCC before LTx.Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide with more than 1 million deaths annually [1]. The prevalence of Hepatitis B and C with consecutive liver cirrhosis and HCC tumor growth leads to an increasing incidence of HCC especially in Europe and the USA [2]. HCC develops in a cirrhotic liver in 80% of cases, with an annual incidence of 2–6% for hepatitis B virus carriers and 3–5% for hepatitis C virus infected individuals. Two decades ago, the prognosis of HCC was devastating with most patients dying within the first year after diagnosis irrespective of their treatment [3]. The development of standardized surveillance strategies and the introduction of the Barcelona-clinic liver cancer classification (BCLC) for clinical management of HCC have significantly improved outcome. In industrialized countries 30–40% of patie