Objective To observe the efficacy and safety of combined treatment of Qizhu Formula and FOLFOX4 on advanced gastric cancer patients after failure of first-line chemotherapy. Methods Totally 44 patients with advanced gastric cancer who failed first-line chemotherapy were divided randomly into treatment group and control group

each with 22 patients. Treatment group was given Qizhu Formula orally

1 dose per day

with FOLFOX4 chemotherapy

whereas control group was merely given FOLFOX4 chemotherapy. The treatments were continuously applied unless progression

or untolerable toxicity

or patients ’ rejection of chemotherapy occured. Improvement of clinical symptoms

quality of life

tumor response

progression free survival（ PFS）

overall survival（ OS）

adverse effects and the expression of P-glycoprotein（ Pg-p）

glutathione S-transferase（ GST-π）

topoisomerase Ⅱ（ Topo-Ⅱ） of two groups were compared. Results Improvement of clinical symptoms

PFS

OS in the treatment group was notedly better than that in the control group（ P < 0. 05 or P < 0. 01）. The expression of Pg-p

GST-π

Topo-Ⅱin treatment group showed no obvious change after treatments（ P > 0. 05）. The expression of Pg-p

Topo-Ⅱ in control group also showed no obvious change after treatments（ P > 0. 05）

but the expression of GST-π after treatments was observably higher than before（ P < 0. 05）. Conclusion Combined treatment of Qizhu Formula and FOLFOX4 on advanced gastric cancer patients who failed first-line chemotherapy has the effect of enhancing efficacy and reducing toxicity. Stabilizing the expression of GST-π may be one of the reasons of its efficacy-enhancing effect.