Clinical trial of nivolumab combined with anlotinib in the treatment of patients with advanced gastric cancer
Objective To observe the clinical efficacy and safety of nivolumab combined with anlotinib in the treatment of patients with advanced gastric cancer.Methods The patients with advanced gastric cancer were randomly divided into control group and treatment group.The control group received oral apatinib capsules 12 mg,once a day,and discontinued treatment for 7 days after 14 days of maintenance therapy.On the basis of control group,the treatment group received intravenous infusion of 3 mg·kg-1 nivolumab,once every two weeks.Two groups were treated for four cycles with 21 days per cycle.The clinical efficacy,tissue polypeptide specific antigen(TPS),carbohydrate antigen 125(CA125),carcinoembryonic antigen(CEA)and adverse drug reactions were compared between two groups.Results In the treatment group,80 cases were enrolled,and 4 cases dropped out and 76 cases were included in the statistical analysis;in the control group,80 cases were enrolled,and 8 cases dropped out and 72 cases were included in the statistical analysis.After treatment,the total effective rates in the treatment and control group weres 78.95％(60 cases/76 cases)and 52.78％(38 cases/72 cases),and the difference was statistically significant(P＜0.05).After treatment,the levels of CEA in the treatment and control groups were(5.34±1.12)and(7.01±0.97)U·mL-1;the levels of CA125 were(22.65±4.27)and(27.61±5.09)U·mL-1;the levels of TPS were(69.21±11.64)and(53.06±10.57)U·mL-1;these differences were statistically significant(all P＜0.05).The adverse drug reactions of two groups were nausea/diarrhea,leukopenia,thrombocytopenia,abnormal liver function,and hypothyroidism.The total incidences of adverse drug reactions in the treatment and control groups were 40.79％and 37.50％without statistically significant difference(P＞0.05).Conclusion Ramucirumab injection combined with anlotinib capsules is more effective than single-agent anlotinib in the treatment of advanced gastric cancer,without increasing the incidence of adverse drug reactions.
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