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Objective:We aimed to analysis the HER2 gene status and its relationship with p21 protein expression in gastric carcinoma.Methods:Fluorescence in situ hybridisation (FISH) and immunohistochemistry (IHC) techniques were used to detect HER2 gene status and p53 protein in 59 cases of gastric cancer.Results:FISH detection of HER2 gene amplification rate was 16.9% (10/59),HER2 gene amplification in 49 cases without copy number gain and gene amplification were a total of 49.2% (29/59).HER2 protein expression was 42.4% (25/59),HER2 gene amplification rates in patients with +++,++ HER2 protein expression were 3/3 and 5/8,while in patients with + HER2 protein expression,it was 2/14,there was significant difference (P < 0.05).p21 protein expression rate was 49.2% (29/59),HER2 gene amplification rates and p21 protein expression had significant difference in tumor invasion depth,lymph node metastasis (P < 0.05);had no statistical significance in histological type,age,gender differences (P > 0.05).Conclusion:HER2 gene amplification rate and gene copy number had positively correlation with p21 protein expression,HER2 gene status and expression of p21 protein combined detection can provide a reference value in gastric cancer metastasis,patient's condition development and prognosis,it also can guide clinical development of individual treatment.