Abstract: Objective: To observe the effect of the therapy of Jianpi Huaji Fuzheng tang on cellular immune function and quality of life in patients with primary liver cancer. Methods:A total of 101 patients with primary liver cancer were divided into the study group and the control group according to the randomized control method, with 50 and 51 cases in each group respectively. The control group was treated with routine treatment,and the study group was additionally treated with Jianpi Huaji Fuzheng tang based on the treatment of the control group. The clinical effects were compared between the two groups; before and after treatment,the changes of mature T lymphocytes(CD3+),inducible T lymphocytes(CD4+ ), cytotoxic T lymphocytes(CD8 + ), immunoglobulin G(IgG), aspartate aminotransferase(AST), alanine aminotransferase(ALT), serum total bilirubin(STB), carcinoembryonic antigen(CEA), alpha- fetoprotein (AFP) and Chinese medicine syndrome scores in the two groups were recorded and compared. Before and after treatment, the living conditions in the two groups were evaluated by Short Form- 36(SF- 36) for quality of life. Results:The total effective rate was 74.00% in the study group,higher than that of 52.94% in the control group(P<0.05). After treatment,the scores of CD4+,IgG and SF-36 in the two groups were increased when compared with those before treatment(P<0.05), and the levels of CD8 + , AST, ALT, STB,CEA and AFP and the Chinese medicine syndrome scores of pain in the liver area,belching,poor appetite and digestion, diarrhea and insomnia were decreased; after treatment, the scores of CD3 + , CD4 +,IgG and SF- 36 in the study group were higher than those in the control group(P<0.05),and the levels of CD8+,AST,ALT,STB,CEA and AFP and the Chinese medicine syndrome scores of pain in the liver area,belching,poor appetite and digestion,diarrhea and insomnia in the study group were lower(P< 0.05). Conclusion:The therapy of Jianpi Huaji Fuzheng tang for primary liver cancer can effectively improve the immune function of patients,enhance the quality of life and clinical effect,improve the indexes of the liver function of patients,and reduce the content of tumor markers.