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HAIC-FOLFOX 联合卡瑞利珠单抗用于不可切除肝细胞癌的临

          床观察
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          祝 平 ,卢西雅,田艳飞(辽宁省肿瘤医院内镜科,沈阳 110042)
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          中图分类号  R735.7;R969.4      文献标志码  A      文章编号  1001-0408(2025)22-2833-05
          DOI  10.6039/j.issn.1001-0408.2025.22.14

          摘  要  目的  探讨基于奥沙利铂和氟尿嘧啶药物组合的肝动脉灌注化疗(即HAIC-FOLFOX)联合卡瑞利珠单抗用于不可切除
          肝细胞癌(HCC)的有效性和安全性。方法  回顾性收集2021年1月1日-2023年3月1日于辽宁省肿瘤医院住院治疗的222例不
          可切除HCC患者的资料,根据治疗方案的不同将其分为对照组(HAIC-FOLFOX联合索拉非尼,117例)和观察组(HAIC-FOLFOX
          联合卡瑞利珠单抗,105例)。比较两组患者治疗4个周期后的近期疗效指标[客观缓解率(ORR)和疾病控制率(DCR)]和远期疗
          效指标[中位总生存期(mOS)和1年内中位无进展生存期(mPFS)],治疗前及治疗4个周期后的肿瘤标志物(甲胎蛋白、癌胚抗原、
          糖类抗原19-9)、免疫功能指标(CD3 、CD4 和CD8  T细胞亚群)水平,以及治疗期间的不良反应发生情况。结果  观察组患者的
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          ORR为55.24%,显著高于对照组的35.90%(P<0.05),而两组患者的DCR比较差异无统计学意义(P>0.05);观察组患者的mOS、
          1年内mPFS(15.22、10.83个月)均显著长于对照组(11.34、8.04个月)(P<0.05)。治疗4个周期后,两组患者的肿瘤标志物水平均
          显著低于同组治疗前,观察组患者的CD3 、CD4  T细胞比例均显著高于同组治疗前(P<0.05);且观察组患者的上述指标均显著
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          优于同期对照组(P<0.05)。观察组发生1~3级免疫相关性肺炎、毛细管增生的患者比例均显著高于对照组(P<0.05),而两组发
          生1~3级发热、乏力、皮疹等不良反应的患者比例比较,差异均无统计学意义(P>0.05)。结论  相较于HAIC-FOLFOX联合索拉
          非尼,HAIC-FOLFOX联合卡瑞利珠单抗可显著提高不可切除HCC患者的ORR,延长mOS和1年内mPFS,有效降低肿瘤标志物
          水平,改善部分免疫功能指标,但会增加免疫相关不良事件的发生风险。
          关键词  肝动脉灌注化疗;卡瑞利珠单抗;索拉非尼;不可切除肝细胞癌;有效性;安全性

          Clinical  observation  of  HAIC-FOLFOX  combined  with  camrelizumab  in  the  treatment  of  unresectable
          hepatocellular carcinoma
          ZHU Ping,LU Xiya,TIAN Yanfei(Dept.  of  Endoscopy,  Liaoning  Cancer  Hospital  &  Institute,  Shenyang
          110042, China)

          ABSTRACT   OBJECTIVE  To  investigate  the  efficacy  and  safety  of  hepatic  arterial  infusion  chemotherapy  based  on  the
          oxaliplatin  and  fluorouracil  drug  combination (HAIC-FOLFOX)  combined  with  camrelizumab  in  the  treatment  of  unresectable
          hepatocellular carcinoma (HCC). METHODS The data of 222 unresectable HCC patients hospitalized at Liaoning Cancer Hospital
          &  Institute  from  January  1,  2021  to  March  1,  2023  were  retrospectively  collected.  Based  on  treatment  regimens,  patients  were
          divided into a control group (HAIC-FOLFOX+sorafenib, n=117) and an observation group (HAIC-FOLFOX+camrelizumab, n=
          105).  Short-term  efficacy  indicators  [objective  remission  rate (ORR)  and  disease  control  rate (DCR)]  and  long-term  efficacy
          indicators  [median  overall  survival (mOS)  and  median  progression-free  survival (mPFS)  within  one  year]  after  4  cycles  of
          treatment, the levels of tumor markers (alpha fetoprotein, carcinoembryonic antigen, carbohydrate antigen 19-9), immune function
          indicators (CD3 ,  CD4 ,  and  CD8   T-cell  subsets)  before  treatment  and  after  4  cycles  of  treatment,  as  well  as  the  occurrence  of
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          adverse  reactions,  were  compared  between  two  groups.  RESULTS  The  ORR  of  the  observation  group  was  55.24%,  which  was
          significantly  higher  than  35.90%  of  the  control  group (P<0.05);  while  there  was  no  statistically  significant  difference  in  DCR
          between  the  two  groups (P>0.05).  The  mOS  and  mPFS  within  1  year  of  the  observation  group (15.33,  10.83  months)  were
          significantly longer than the control group (11.34, 8.04 months) (P<0.05). After 4 cycles of treatment, tumor marker levels of the
          two groups were significantly lower than before treatment, and the proportions of CD3  and CD4  T cells were significantly higher
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          than  before  treatment (P<0.05).  Above  indexes  of  the  observation  group  were  significantly  better  than  the  control  group  at  the
          same time (P<0.05). The proportions of patients in the observation group who developed grade 1-3 immune-related pneumonia and
          capillary  proliferation  were  significantly  higher  than  the  control  group (P<0.05),  while  there  were  no  statistically  significant
                                                             differences  in  the  proportions  of  patients  experiencing  grade  1-
             Δ 基金项目 辽宁省科学技术计划项目(No.2022-BS-061)              3  adverse  reactions  such  as  fever,  fatigue  and  rash  between
             *第一作者 主治医师,博士。研究方向:肝癌的临床诊疗。E-mail:
                                                             two  groups  (P>0.05).  CONCLUSIONS  Compared  with
          sunyijun0513@163.com
             # 通信作者 主治医师,硕士。研究方向:肝癌的临床诊疗。E-mail:             HAIC-FOLFOX  combined  with  sorafenib,  HAIC-FOLFOX
          fly23411015@126.com                                combined  with  camrelizumab  can  significantly  improve  the


          中国药房  2025年第36卷第22期                                              China Pharmacy  2025 Vol. 36  No. 22    · 2833 ·
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