放疗联合靶向免疫新辅助治疗肝内胆管细胞癌的安全性与疗效  

Safety and efficacy of radiotherapy combined with targeted neoadjuvant immunotherapy for intrahepatic cholangiocarcinoma

作　　者：孙志鹏 束斌[1] 王良[1] 黄鑫[1] 王鹏飞[1] 李广欣 王小娟 黎功 杨世忠[1] Zhipeng Sun;Bin Shu;Liang Wang;Xin Huang;Pengfei Wang;Guangxin Li;Xiaojuan Wang;Gong Li;Shizhong Yang(Hepatobiliary and Pancreatic Center,Beijing Tsinghua Changgung Hospital(Institute for Precision Medicine,School of Clinical Medicine,Tsinghua University),Beijing 102218,China;Department of Radiation,Beijing Tsinghua Changgung Hospital(Institute for Precision Medicine,School of Clinical Medicine,Tsinghua University),Beijing 102218,China)

机构地区：[1]清华大学附属北京清华长庚医院肝胆胰中心(清华大学临床医学院清华大学精准医学研究院),102218 [2]清华大学附属北京清华长庚医院放疗科(清华大学临床医学院清华大学精准医学研究院),102218

出　　处：《中华肝脏外科手术学电子杂志》2025年第1期92-96,共5页Chinese Journal of Hepatic Surgery(Electronic Edition)

基　　金：国家自然科学基金重大项目(82090052);清华大学精准医学科研项目(2022ZLA007);中国医学科学院院外创新单元(2019-I2M-5-056)。

摘　　要：目的探讨放疗联合靶向免疫新辅助治疗肝内胆管细胞癌(ICC)的安全性与疗效。方法回顾性分析2020年1月至2022年11月在北京清华长庚医院接受放疗联合靶向免疫新辅助治疗的6例ICC患者临床资料。患者均签署知情同意书,符合医学伦理学规定。其中男4例,女2例;年龄52~77岁,中位年龄66岁。根据实体瘤反应评估标准1.1,将肿瘤疗效评估为完全缓解(CR)、部分缓解(PR)、疾病稳定(SD)、疾病进展(PD),并计算客观缓解率(ORR)和疾病控制率(DCR)。不良事件根据不良事件通用术语标准5.0版进行评估。生存分析采用Kaplan-Meier法。结果新辅助治疗期间疗效达到PR 5例、SD 1例。ORR和DCR分别为5/6和6/6。总体不良反应发生率为4/6,3级以上不良反应为1/6。随访期间存活6例,其中无进展存活5例。生存分析显示,中位OS为26.1个月,中位PFS为19.0个月。6例患者新辅助治疗后R0切除率为100%,术后1年总体生存率为100%,无进展生存率为83.3%。结论放疗联合靶向免疫新辅助治疗方案对于ICC安全性较好,有效性确切。Objective To evaluate the safety and efficacy of radiotherapy combined with targeted neoadjuvant immunotherapy for intrahepatic cholangiocarcinoma(ICC).Methods Clinical data of 6 ICC patients who received radiotherapy combined with targeted immunotherapy in Beijing Tsinghua Changgung Hospital from January 2020 to November 2022 were retrospectively analyzed.The informed consents of all patients were obtained and the local ethical committee approval was received.Among them,4 patients were male and 2 female,aged from 52 to 77 years,with a median age of 66 years.According to the Response Evaluation Criteria in Solid Tumors(RECIST version 1.1),clinical efficacy was evaluated as complete response(CR),partial response(PR),stable disease(SD)and progressive disease(PD),respectively.The objective response rate(ORR)and disease control rate(DCR)were calculated.The severity of adverse events was evaluated using the Common Terminology Criteria for Adverse Events(CTCAE)version 5.0.Survival analysis was performed by Kaplan-Meier method.Results During the neoadjuvant treatment,5 cases obtained PR and 1 case achieved SD.The ORR and DCR were 5/6 and 6/6,respectively.The overall incidence of adverse reactions was 4/6,and 1/6 for>grade 3 adverse reactions.During follow-up,6 patients survived,including 5 cases of progress-free survival(PFS).Survival analysis showed that the median overall survival(OS)was 26.1 months and the median PFS was 19.0 months.The R0 resection rate reached 100% in 6 patients after neoadjuvant therapy.The postoperative 1-year OS rate was 100%and 83.3% for 1-year PFS.Conclusions Radiotherapy combined with targeted neoadjuvant immunotherapy is safe and efficacious for ICC.

关 键 词：肝内胆管细胞癌 胆管肿瘤 新辅助治疗 放射治疗 靶向治疗 免疫治疗 

分 类 号：R735.8[医药卫生—肿瘤]