Clinical trial of using cinobufotalin combined with fuquintinib in third-line therapy of advanced colorectal cancer
Objective To investigate the effect of cinobufotalin combined with fuquintinib on immune function,tumor markers and angiogenesis in patients with advanced colorectal cancer receiving the third-line treatment by combined use of the two drugs.Methods A total of 58 patients with advanced colorectal cancer undergoing the third-line treatment in the Affiliated Hospital of Inner Mongolia Medical University from December 2022 to November 2023 were randomly divided into a control group(treated with fuquintinib,n=29)and an observation group(treated with fuquintinib in combination with cinobufotalin capsules,n=29).The changes in immune function,tumor markers and angiogenic factors before and after treatment were compared between the two groups.Results After treatment,the clinical benefit rate(CBR)was significantly higher in the observation group than in the control(χ2=4.858,P<0.05).The levels of CD4+,CD8+and CD4+/CD8+in both groups were higher after than before the treatment(P<0.05).Moreover,they were(39.97±7.00)%,(24.42±0.97)%and(1.61±0.37)in the observation group,which were higher than those in the control((33.23±6.13)%,(23.34±0.85)%and(1.43±0.30))(t=3.900,4.509,2.035,all P<0.05).The levels of CA125,CA19-9 and CEA were decreased in both groups after treatment(all P<0.05),and they were significantly lower in the observation group than in the control((32.22±5.23)μg·mL-1 vs(41.95±6.20)μg·mL-1,(28.59±4.03)μg·mL-1 vs(36.19±5.06)μg·mL-1,(16.12±2.46)μg·mL-1 vs(23.77±4.01)μg·mL-1,t=6.460,6.327,8.757,all P<0.05).Meanwhile,the levels of VEGF,HIF-1α and TGF-β1 were decreased in both groups after treatment(all P<0.05),and they were lower in the observation group than in the control((550.96±80.33)pg·mL-1 vs(600.44±83.22)pg·mL-1,(41.55±5.12)ng·L-1 vs(58.77±6.60)ng·L-1,(13.19±2.98)pg·mL-1 vs(18.76±3.77)pg·mL-1,t=2.304,11.102,6.242,all P<0.05).Conclusion Cinobufotalin capsules combined with fuquitinib for the third-line treatment of advanced colorectal cancer can downregulate tumor markers CA125,CA19-9 and CEA,regulate immune function and reduce tumor angiogenesis in the patients.