Page 109 - 南京医科大学自然版

第46卷第7期 南京医科大学学报（自然科学版）
2026年7月 Journal of Nanjing Medical University（Natural Sciences） ·1055 ·

·临床研究·

胆道恶性肿瘤合并高危复发因素患者术后辅助靶向联合免疫

治疗的安全性及有效性分析

张寅祺，兰 欣，韩国勇，孔连宝，吴金道 *

南京医科大学第一附属医院肝胆中心，江苏 南京 210029

［摘 要］ 目的：探讨术后辅助靶向联合免疫治疗在合并高危复发因素的胆道恶性肿瘤患者中的安全性与有效性。方法：回
顾性分析2023年1—12月于南京医科大学第一附属医院接受手术切除后不愿接受辅助化疗、自愿选择靶向联合免疫治疗的
24例胆道恶性肿瘤合并高危复发因素患者的临床资料。记录患者临床病理特征、无复发生存期（relapse⁃free survival，RFS）、总
生存期（overall survival，OS）及不良反应（adverse event，AE）发生情况。采用Kaplan⁃Meier 法进行生存分析，Cox 比例风险回归
分析影响RFS的因素。结果：24例患者随访期间，12例（50.00%）患者复发，7例（29.17%）患者死亡，中位RFS为12个月，中位
OS未达到。其中，R0切除合并高危复发因素患者的中位RFS、中位OS均未达到，R1切除患者的中位RFS为8个月，中位OS未
达到。R0切除合并高危复发因素患者的RFS率、OS率均显著高于R1切除患者。预后因素分析显示，年龄<60岁、肿瘤单发、
R0 切除、无淋巴结转移、无血管侵犯、单一复发高危因素为影响患者 RFS 的因素（P 均< 0.05）。安全性方面，AE 发生率为
79.17%（19/24），3级AE发生率为8.33%（2/24），无治疗相关死亡事件发生。结论：术后辅助靶向联合免疫治疗在合并高危复发
因素的胆道恶性肿瘤患者中显示出一定的疗效，且安全性可控。年龄<60岁、肿瘤单发、R0切除、无淋巴结转移、无血管侵犯、
单一复发危险因素为本研究中影响患者RFS的因素。
［关键词］ 胆道恶性肿瘤；高危复发因素；靶向治疗；免疫治疗；有效性；安全性
［中图分类号］ R735.8 ［文献标志码］ A ［文章编号］ 1007⁃4368（2026）07⁃1055⁃09
doi：10.7655/NYDXBNSN260395

Safety and efficacy analysis of postoperative adjuvant targeted therapy combined with
immunotherapy in patients of biliary tract carcinoma with high⁃risk factors for recurrence

ZHANG Yinqi，LAN Xin，HAN Guoyong，KONG Lianbao，WU Jindao *
Hepatobiliary Center，the First Affiliated Hospital of Nanjing Medical University，Nanjing 210029，China

［Abstract］ Objective： To explore the safety and efficacy of postoperative adjuvant targeted therapy combined with immunotherapy
in patients of biliary tract carcinoma with high⁃risk factors for recurrence. Methods：A retrospective analysis was performed on the
clinical data of 24 patients with biliary tract carcinoma complicated with high ⁃ risk factors for recurrence，who underwent surgical
resection in the First Affiliated Hospital of Nanjing Medical University from January to December 2023，declined adjuvant
chemotherapy，and voluntarily opted for targeted therapy combined with immunotherapy. The clinicopathological characteristics，
relapse ⁃ free survival（RFS），overall survival（OS），and incidence of adverse events（AE）of the enrolled patients were recorded.
Survival analysis was performed using the Kaplan ⁃ Meier method，and the Cox proportional hazards regression model was used to
analyze the factors affecting RFS. Results：During the follow⁃up of the 24 patients，12 patients（50.00%）developed recurrence and
7 patients（29.17%）died. The median RFS was 12 months，and the median OS was not reached. Among them，the median RFS and
median OS were not reached in patients with R0 resection and high⁃risk factors for recurrence，while the median RFS was 8 months and
the median OS was not reached in patients with R1 resection. The RFS rate and OS rate of patients with R0 resection and high⁃risk
factors for recurrence were significantly higher than those of patients with R1 resection. Prognostic factor analysis showed that age <
60 years，single tumor，R0 resection，no lymph node metastasis，no vascular invasion，and single high⁃risk recurrence factor were

［基金项目］ 北京陈菊梅公益基金会（L2025070182）
通信作者（Corresponding author），E⁃mail：wujindao@njmu.edu.cn（ORCID：0000⁃0002⁃2317⁃6565）
∗