The aim of this study was to evaluate whether Traditional Chinese Medicine (TCM) improves immune response for unresectable hepatocellular carcinoma (UHCC) after transcatheter arterial chemoembolization (TACE) by using meta-analysis of data from the literature involving available randomized controlled trials of TCM in combination with TACE compared with that of TACE alone. Literature retrieval was conducted through the Cochrane Library, MEDLINE, CENTRAL, Embase, CBMdisc, and CNKI, without language limitations. Based on our search criteria, we found 12 trials involving 1,008 patients. Our results showed that the differences of pooled weighted mean difference before and after treatment and 95% confidence intervals (CIs) were 13.63 (8.96-18.69; P = .0001) for the proportion of CD3(+) T cells, 10.56 (6.91-14.21; P = .0001) for the proportion of CD4(+) T cells, -3.40 (-6.83 to 0.03; P = .052) for the proportion of CD8(+) T cells, 0.54 (0.42-0.66; P = .0001) for the ratio of CD4(+)/CD8(+), and 12.34 (7.26-17.41; P = .0001) for the proportion of natural killer cells. No serious adverse events were reported. Traditional Chinese Medicine in combination with TACE improves the immune response of patients with UHCC. However, considering the strength of the evidence, additional randomized controlled trials are needed before TCM plus TACE can be recommended routinely. Copyright Â© 2011 Elsevier Inc. All rights reserved.