The efficacy and safety of transarterial chemoembolization (TACE) plus sorafenib for patients with hepatocellular carcinoma (HCC) have been explored by many studies, but the results were controversial. Therefore, we performed this meta-analysis of high-quality randomized controlled trials to evaluate the efficacy and safety of TACE plus sorafenib versus TACE monotherapy in the early or intermediate stage HCC.

Multi-databases were systematically searched to identify all eligible literatures. The hazard ratio (HR) or risk ratio (RR) with 95% confidence intervals (95%CIs) for time to progression (TTP), overall survival (OS), objective response rate (ORR), disease control rate (DCR) and the incidence of treatment-related adverse events (AEs) were pooled using a fixed or random effect model in STATA 12.0.

Four randomized controlled trials, including a total of 887 patients with early or intermediate stage HCC, were included in this meta-analysis. The pooled results showed that TACE plus sorafenib significantly improved TTP (HR=0.77, 95% CI: 0.64–0.92; P=0.005). Nevertheless, the OS (HR=0.97, 95% CI: 0.72–1.29; P=0.828), ORR (RR=1.20, 95% CI: 0.88–1.64; P=0.257) and DCR (RR=1.04, 95% CI: 0.90–1.02; P=0.568) were not improved. The incidence of treatment-related AEs was higher in the TACE plus sorafenib.

Evidences from the meta-analysis of high-quality randomized controlled trials indicate that TACE plus sorafenib can significantly improve TTP but not OS, ORR and DCR in early or intermediate stage HCC. In addition, the combination therapy increases the adverse events which usually disturb the treatment progress and should be increased attention.