Analysis of the registration characteristics of pancreatic cancer clinical trials based on data from ClinicalTrials.gov

HE Jing-long; XIE Lei; XU Yang-mei; CHENG Bin

doi:10.20251/j.cnki.1003-3734.2025.10.006

Abstract：Objective:To deeply understanding the development situation and registration characteristics of clinical trials for pancreatic cancer,and to provide insights into enhancing clinical research.Methods:A comprehensive search of all pancreatic cancer clinical trials on ClinicalTrials.gov was conducted up to July 3,2024.The basic characteristics,methodological design,and key parameters of these trials were statistically analyzed.Results:A total of 4 409 pancreatic cancer clinical trials were searched worldwide,with 542 were conducted in China,both showing an upward trend.1705(38.7%)trials had been completed,971(22.0%)were recruiting participants,and 434(9.8%)had been terminated.These trials included 1 326(30.1%)Phase Ⅰ trials,1 550(35.1%)Phase Ⅱ trials,and 249(5.6%)Phase Ⅲ trials.Intervention studies comprised 80.0%of the trials,while observational studies accounted for19.6%.The primary objectives of these trials were treatment(2849,64.6%),diagnosis(273,6.2%),and supportive care(154,3.5%).In terms of study design,41.2%of the trials employed a single-arm design,27.7%used a parallel design,and 6.1%utilized a sequential design.Additionally,1095(24.8%)trials were randomized and400(9.1%)were blinded.The main interventions were chemotherapy(2 477,56.2%)and surgery(684,15.5%).Among the 249 PhaseⅢclinical trials,94(37.8%)used Overall Survival as the primary endpoint,24(9.6%)used Progression-Free Survival,with other common endpoints including adverse events(5.2%)and Disease-Free Survival(4.4%).Conclusion:The number of clinical trials for pancreatic cancer has rapidly increased.Chinese researchers should focus on improving trial design,pay more attention to diagnostic trials,enhance the application of randomization and blind methods,and select more scientific and objective end-point outcomes to further improve the clinical study of pancreatic cancer.