To observe the therapeutic effect of invigorating Spleen and tonifying Kidney decoction combined with cinobufotalin on gastrointestinal malignancies. Methods:A total of 64 patients were randomly divided into 2 groups. The treatment group was treated with invigorating Spleen and tonifying Kidney decoction combined with cinobufotalin, while the control group was treated with cinobufotalin. Results: The symptoms of treatment group, such as fatigue, dizziness, poor appetite, thirst, night sweats, had significantly improved than control group (P<0.01). There was significant difference between treatment group and control group in the quality of life (KPS), immune parameters and clinical benefit rate（P<0.05）. The differences of peripheral blood hemoglobin, white blood cells, thrombocytopenia and other adverse reactions between the two groups were significant (P<0.05). But in solid tumor response rate (CR + PR), the difference between two groups had no statistical significance (P> 0.05). Conclusion: The invigorating Spleen and tonifying Kidney decoction combined with cinobufotalin can cure gastrointestinal malignancies, improve the clinical symptoms and quality of life, enhance the level of the immune parameters, and reduce the adverse reactions in the treatment.