| Objective:To compare the clinical efficacy and safety of apatinib combined supportive treatment and supportive care in the treatment of patients with advanced biliary tract cancer by conducting a rigorous controlled prospective study.It is hoped that targeted therapy can prolong the survival of patients with biliary tract cancer,with a safer and more reliable clinical effect.Methods:In the case of informed consent,patients who met the inclusion and exclusion criteria were enrolled(apatinib combined supportive treatment regimen or best supportive care group),receiving apatinib combined supportive treatment and best supportive care,respectively.The progress-free survival(PFS)and overall survival(OS)were the main research indicators.The objective response rate(ORR)and local control rate(DCR)were used as secondary indicators to evaluate the condition.The clinical benefit and the adverse reactions of the two treatment groups were observed.Results:In this prospective clinical study,the median progression-free survival(mPFS)of the apatinib combined supportive treatment group was 4.0 months(95%CI 3.613-4.387),and the median progression-free survival(mPFS)of the support group was 3.3 Months(95%CI0.959-5.641),There was no statistical difference in PFS between the two groups(X~2=6.833,p=0.009;p≤0.05).The median overall survival(mOS)of the apatinib combined supportive treatment group was 6.4months(95%CI 4.156-8.44),and the median overall survival(mOS)of the support group was 6.3 months(95%CI 5.186-7.414),There was no statistical difference in OS between the two groups(X~2=1.823,p=0.177;p>0.05).The objective response rate(ORR)was 20%and the disease control rate(DCR)was 80%in the apatinib combined supportive treatment group.The most common grade 3-4 adverse events were hepatic dysfunction[3 patients in the apatinib group(30%)]and hand-foot syndrome[3 patients in the apatinib group(30%)].There were no fatal adverse reactions associated with apatinib during the study.Conclusions:Compared with the best supportive treatment group,apatinib has an advantage in prolonging the progress-free survival(PFS)in the treatment of advanced biliary tract cancer.But there was no advantage of improving overall survival(OS).Apatinib shows a good objective response rate(ORR)and disease control rate(DCR)in the treatment of advanced biliary tract cancer. |
