Objective To evaluate the efficacy of Jianpi-Xiaozheng recipe combined with chemotherapy in patients with late gastric cancer. Methods A total of 124 patients with late gastric cancer were randomly divided into a control group and a treatment group by random number table method, with 62 cases in each group. The patients in the control group received chemotherapy with S-1 and oxaliplatin (SOX), and those in the treatment group received Jianpi-Xiaozheng recipe combined with SOX chemotherapy. The treatment response was evaluated using the response evaluation criteria in solid tumors. The quality of life and physical status were evaluated with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30) and Karnofsky Performance Status (KPS), respectivly. The serum levels of tumor biomarkers, carbohydrate antigen 199 (CA199) and carbohydrate antigen 72-4 (CA72-4) were detected before and after treatment. Results The response rate (complete or partial response) in the treatment group was significantly higher than that in the control group (62.9%vs. 43.5%;χ2=4.665, P=0.031). The scores of QLQ-C30 (46.8 ± 6.3 vs. 42.2 ± 5.9;t=4.196, P=0.001) and KPS (79.1 ± 7.8 vs. 72.0 ± 7.5;t=5.167, P=0.000) in the treatment group were significantly higher than those in the control group. The serum levels of CA199 (61.7 ± 16.5 U/ml vs. 113.3 ± 21.4 U/ml;t=15.036, P=0.000) and CA72-4 (27.9 ± 9.6 U/ml vs. 34.3 ± 9.7 U/ml;t=3.693, P=0.001) in the treatment group were significantly lower than those in the control group. Conclusions Jianpi-Xiaozheng recipe combined with chemotherapy can increase response rate, decrease the serum levels of tumor biomarkers, and improve the quality of life in patients with late gastric cancer.

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