Objective: To observe the effect of complex Banmao capsules combined with FOLFOX4 regimen in the treatment of advanced gastrointestinal malignancies patients.Method: One hundren and twenty cases with advanced gastrointestinal malignancies were randomly divided into treatment group and simple group with 60 cases in each group.The two groups were given FOLFOX4 regimen.The treatment group was additionally given complex Banmao capsules(1 g

Tid)for 4 weeks. Result: The karnofsky performance status(KPS) improvement rate in treatment group was 58.3%

while in simple group was 33.3%

two groups had significant difference(P<0.05).All patients with advanced gastrointestinal malignancies showed that the CD4+T cells and natural killer(NK) cells were lower than that of the controlled group(P<0.05)

the CD8+T cells were higher than those of the control group(P<0.05). After treatment the CD4+T cells and NK cells in the treatment group[CD4+(42.8±8.2)%

NK(22.1±3.5)%] was increased more significantly than simple group[CD4+(37.8±7.6)%

NK(16.7±5.3)%] (P<0.05). After treatment the CD8+ T cells in the treatment group were decreased more significantly than simple group[CD8+(25.4±3.4)% vs (27.6±6.2)%] (P<0.05). The incidence of toxicity after chemotherapy in the treatment group was lower than simple group (P<0.05). Conclusion: The cellular immunological functions were inhibited in patients with advanced gastrointestinal malignancies.FOLFOX4 regimen could reverse the immune suppression state in patients with advanced gastrointestinal malignancies. The combination of FOLFOX4 regimen and Fufang Banmao Capsules could remarkably improve immunological functions

quality of life and reduce toxicity after FOLFOX4 chemotherapyin advanced gastrointestinal malignancies patients.