objective:to study xiaoaijiedufang,which under the guidance of “cancer toxin”theory of professor zhou zhongying for long－term clinical practice as an effective anti－cancer drugs,the immune function of the chinese medicine on patients with advanced malignant tumor. Methods:one hundred and ninety－eight cases of stage Ⅲ~Ⅳ patients with malignant tumor were randomly divided into the treatment group (chemotherapy combined with chinese medicine group) of 120 cases and the control group (chemotherapy alone) of 78 cases. The patients in the treatment group took xiaoaijiedufang of chinese medicine at the begining of the first cycle of chemotherapy,and took 2 to 3 months consecutively. Results:the number of cd3+,cd4+,cd4+/cd8+ and nk activity had a significant difference between the control group and treatment group (p <0.01). Conclusion:the results indicated that xiaoaijiedufang combined with chemotherapy has a certain therapeutic effect on improving anti－tumor immunity of patients.