A Prospective,Multicenter Study of Involved-Field Radiotherapy plus Camrelizumab versus Radiotherapy Alone in Elderly Patients with Esophageal Squamous Cell Carcinoma
LIU Lihua
LI Xue
LIU Minmin
REN Jiapeng
WANG Ziyu
LI Mengshi
LI Hongqi
Abstract：Objective To explore the efficacy,safety and prognostic factors of involved-field radiotherapy combined with camrelizumab immunotherapy versus involved-field radiotherapy alone in elderly patients with esophageal squamous cell carcinoma.Methods A prospective,multicenter,randomized controlled study was designed.From November 2021 to November 2023,80 elderly patients with esophageal squamous cell carcinoma aged over 70 years were enrolled from Heze Hospital of Traditional Chinese Medicine and the Air Force Medical Center,and randomly divided into Group A(involved-field radiotherapy alone+placebo)and Group B(involved-field radiotherapy combined with camrelizumab),with 40 patients in each group.General clinical data,short-term efficacy,long-term efficacy,and toxicities were compared between the two groups.Multivariate Cox regression analysis was used to analyze the prognostic factors in elderly patients with esophageal squamous cell carcinoma.Results The overall response rate of Group B(67.50%)was higher than that of Group A(45.00%),and the difference was statistically significant(P<0.05).All 80 elderly patients with esophageal carcinoma completed follow-up.The last follow-up was until December 2024,with a median follow-up time of 28.50 months.At the last follow-up,the median overall survival(OS)of Group A and Group B was 18.90 months and 26.70 months,respectively.Kaplan-Meier survival curve analysis showed that the 18-month overall survival rate of Group A was 42.50%,which was lower than that of Group B(60.00%)(P<0.05).There were no statistically significant differences in the incidence and severity of radiation injury,radiotherapy-related pulmonary changes,gastrointestinal reactions,hematological toxicity,abnormal liver and renal function,and immune-related adverse events between the two groups(P>0.05).Univariate Cox proportional hazards regression analysis revealed that clinical stage,maximum tumor diameter,ECOG score,PD-1 expression,and PD-L1 expression were risk factors for the prognosis of elderly patients with esophageal squamous cell carcinoma,while treatment modality and short-term therapeutic effect were protective factors(P<0.05).Multivariate Cox proportional hazards regression analysis showed that clinical stage and maximum tumor diameter were independent risk factors for the prognosis of elderly patients with esophageal squamous cell carcinoma,while treatment method and short-term efficacy were independent protective factors(HR=2.440,95%CI:1.275-4.668,P=0.007;HR=2.555,95%CI:1.436-4.546,P=0.001;HR=0.313,95%CI:0.168-0.584,P<0.001;HR=0.338,95%CI:0.182-0.629,P=0.001).Conclusion Compared with involved-field radiotherapy alone,involved-field radiotherapy combined with immunotherapy can improve the short-term overall response rate and overall survival rate in elderly patients with esophageal squamous cell carcinoma without significantly increasing treatment-related adverse reactions.Furthermore,involved-field radiotherapy combined with immunotherapy is an independent protective factor for the prognosis of these patients.
Keywords：involved-field radiotherapyimmunotherapyesophageal squamous cell carcinomaelderly patientsprospective study
Publication Date：2026-03-20
Online Publishing Date：2026-03-26(First online date of this platform, not the publication date of the document)
Pages：7( 441-447 )