Abstract

Abstract Background and Aims: The present study was carried out to test the hypothesis that interferon‐α (IFN‐α) treatment would reduce or postpone the recurrence rate and improve the overall survival rate in patients after transarterial chemoembolization (TACE) treatment of hepatitis B virus (HBV) related unresectable hepatocellular carcinoma (HCC). Methods: 216 patients with unresectable HBV‐related HCC were randomized into a TACE group and a TACE‐IFN group, each group had 108 patients. In the TACE‐IFN group, patients received IFN‐α1b at a dose of 3 million units (mu) three times a week by intramuscular injection one week after/before TACE treatment, for 48 weeks. Results: The median disease‐free survival in the TACE‐IFN treatment group was 23.6 months (95% CI: 21.4–25.8) and 20.3 months (95% CI: 15.8–24.8) in the TACE group ( P = 0.027). The disease free rate at 24 months in the TACE group was lower than in the TACE‐IFN group (39.8% vs 59.3%, P = 0.004). The median overall survival was 29 months (95% CI: 27.5–32.1) in the TACE‐IFN group and 26 months (95% CI: 20.1–31.9) in the TACE group ( P = 0.003). The 2‐year overall survival in the TACE‐IFN group was higher than in the TACE group (72.2% vs 52.8%, P = 0.003). Conclusions: IFN‐α treatment reduced recurrence and improved the survival of patients after TACE treatment of HBV‐related HCC, with acceptable toxicities.