AIM: To investigate the therapeutic effects of Fuzheng Yiliu (strengthening the body resistance to inhibit tumor)decoction combined with chemotherapy on the patients with intermediate and late stage gastrointestinal cancer.METHODS: Sixty patients were randomly divided into treatment group (chemotherapy combined with Fuzheng Yiliu decoction) and control group (chemotherapy alone).Four indexes, including the tumor recent remission rate (RR), the change of main symptoms, the toxic and side effects caused by chemotherapy and the change of performance status, were observed in the patients. Peripheral blood contents of CD3+, CD4+, CD8+ cells, CD4+/CD8+ and soluble interleukin-2 receptor (sIL-2R) were tested before and after treatment and the values were compared with those of healthy peoples.RESULTS: The improving rate of main symptoms (69.6%)and performance status (56.7%) were significantly higher in the treatment group than in the control group (34.8%, 26.7%,P＜0.05). The occurrence rates of grade Ⅱ toxic and sideeffects on both bone marrow (13.3%) and digestive tract (30%) were lower in the treatment group compared to the control group (36.7%, 63.3%, P＜0.05). Before treatment,the proportion of CD3+, CD4+ and CD4+/CD8+ decreased and the proportion of CD8+ and sIL-2R raised markedly both in the control group and treatment group as compared to the healthy people. After treatment, that increased of CD3+, CD4+,CD4+/CD8+ increased (62.25±10.01% vs68.31±9.72%,36.83±10.44% vs42.6±9.62%, 1.24±0.65 vs L.66±0.85,P＜0.05) and the values of CD8+ and sIL-2R deceased obviously (33.06±7.69% vs 29.24±6.25%, 588.23±216.86 U/mL vs 475.87±211.36 U/mL, P＜0.05) in the treatment group,whereas these values were opposite in the control group (64.22±6.91% vs 60.63±5.75%, 35.62±7.49% vs31.53±5.53%,32.95±8.28% vs 37.14±7.48%, 1.17±0.43 vs 0.94±0.43,573.63±214.32 U/mL vs 692.17±221.33 U/mL, P＜0.05).CONCLUSION: Fuzheng Yiliu decoction can enhance therapeutic effects of chemotherapy on malignant gastrointestinal tumor, and also reduce the toxic and side effects on bone marrow and digestive tract, thereby improving the quality of life and cellular immunity in patients with malignant gastrointestinal tumor.