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Objective:To observe the clinical effects of kanglaite (KLT)capsules combined with transcatheter arterial chemo- embolization(TACE)in treating patients with mid or late-stage primary hepatocellular carcinoma (HCC).Methods:Sixty-five cases were randomly divided into 2 groups.32 patients in combination group received the treatment of KLT capsules+TACE and 33 patients in control group were treared with TACE alone.The objective response rate(RR).serum alpha fetoprotein (AFP),peripheral blood T lymphocyte subgroups(T-LS),quality of life(QOL),time to progression(TTP)and adverse reaction were observed and compared between 2 groups.Results:The objective response rate and serum alpha fetoprotein levels had no significant difference between the two groups (P＞0.05).Combination group was superior to control group in quality of life(QOL).time to progression(TTP),peripheral blood T lymphocyte subgroups(CD3+,CD4+,CD4+＼CD8 ratio)and liver adverse reactions,with significant differences (P＜0.05).Conclusion:KLT capsules combined with TACE is an effective method to treat primary hepatocellular carcinoma (HCC) patients who have lost the opportunity of surgical therapy.