收稿日期: 2025-11-24
修回日期: 2026-01-14
录用日期: 2026-01-15
网络出版日期: 2026-03-26
基金资助
江苏省中医药学会科研项目(CYTF2024055);苏州市科技发展计划(医疗卫生科技创新)重点项目(SYW2024015);江苏大学临床医学科技发展基金研究项目(JLY2021121);苏州市科技计划项目(SKJY2021004);苏州市“科教强卫”项目(MSXM2025058)
Sintilimab combined with chemotherapy for unresectable locally advanced ESCC: An analysis of efficacy and prognosis
Received date: 2025-11-24
Revised date: 2026-01-14
Accepted date: 2026-01-15
Online published: 2026-03-26
目的 探讨信迪利单抗联合化疗转化治疗不可切除局部晚期食管鳞癌的疗效与预后。 方法 回顾性分析2022年7月至2024年8月苏州大学附属张家港医院收治的82例不可切除局部晚期食管鳞状细胞癌患者,根据治疗方案不同分为对照组(仅TP方案)29例和联合组(信迪利单抗联合TP方案)53例。两组均以3周为1个治疗周期,完成4个周期基础治疗后,联合组继续信迪利单抗单药维持治疗直至疾病进展或出现不可耐受毒性。比较两组转化治疗成功率、客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS),治疗前后血清肿瘤标志物[癌胚抗原(CEA)、细胞角蛋白19片段(CYFRA21-1)、鳞状细胞癌抗原(SCC-Ag)]水平、程序性死亡受体-1(PD-1)、程序性死亡受体-1配体(PD-L1)及不良反应发生率、病理缓解率(MPR)。 结果 联合组转化治疗成功率为35.85%,显著高于对照组的13.79%(P < 0.05);联合组ORR和DCR分别为60.38%和88.68%,均显著高于对照组的34.48%和68.97%(P < 0.05);联合组中位PFS为9.6个月,显著长于对照组的6.2个月(Log-rank χ2 = 9.872,P = 0.002);联合组中位OS为17.8个月,显著长于对照组的12.1个月(Log-rank χ2 = 12.543,P < 0.001);治疗后,联合组CEA、CYFRA21-1、SCC-Ag和PD-1、PD-L1异常例数占比均显著低于对照组(P < 0.05);联合组MPR发生率(63.16%)显著高于对照组(25.00%)(P < 0.05)。 结论 信迪利单抗联合紫杉醇脂质体+顺铂方案可显著提升不可切除局部晚期食管鳞状细胞癌转化治疗成功率,改善短期疗效与长期生存,且安全性良好,值得进一步推广应用。
倪晨 , 王少开 , 宋宇 , 陶晨洁 , 蒋健 , 陈志鹏 , 朱惠平 . 信迪利单抗联合化疗转化治疗不可切除局部晚期食管鳞癌的疗效与预后分析[J]. 实用医学杂志, 2026 , 42(6) : 981 -990 . DOI: 10.3969/j.issn.1006-5725.2026.06.010
Objective To explore the effect of conversion therapy with sintilimab combined with the TP chemotherapy regimen in locally advanced unresectable esophageal squamous cell carcinoma (ESCC) and its influence on prognosis. Methods A total of 82 patients with locally advanced unresectable ESCC who were admitted to Zhangjiagang Hospital Affiliated to Suzhou University between July 2022 and August 2024 were retrospectively analyzed. Based on different treatment regimens, they were categorized into the control group (receiving the TP regimen, 29 cases) and the combination group (receiving sintilimab in combination with the TP regimen, 53 cases). After 4 cycles of basic treatment (3 weeks per cycle), the combination group was administered sintilimab monotherapy until disease progression or intolerable toxicity occurred. The success rate of conversion therapy, objective response rate (ORR), disease control rate (DCR), progression - free survival (PFS), overall survival (OS), levels of serum tumor markers [carcinoembryonic antigen (CEA), cytokeratin 19 fragment 21-1 (CYFRA21-1), squamous cell carcinoma antigen (SCC-Ag), programmed death-1 (PD-1), and programmed death-ligand 1 (PD-L1)] before and after treatment, incidence of adverse reactions, and major pathological response (MPR) were compared between the two groups. Results The success rate of conversion therapy in the combination group was significantly higher than that in the control group (35.85% vs. 13.79%, P < 0.05). The ORR and DCR in the combination group were 60.38% and 88.68% respectively, which were significantly higher than those in the control group (34.48% and 68.97% respectively, P < 0.05). The median PFS in the combination group was significantly longer than that in the control group (9.6 months vs. 6.2 months, Log-rank χ2 = 9.872, P = 0.002), and the median OS was also significantly longer than that in the control group (17.8 months vs. 12.1 months, Log-rank χ2 = 12.543, P < 0.001). After treatment, the levels of serum CEA, CYFRA21-1, and SCC-Ag, the proportions of cases with abnormal conditions and PD-L1 in the combination group were significantly lower than those in the control group (P < 0.05). The incidence of MPR in the combination group was significantly higher than that in the control group (63.16% vs. 25.00%, P < 0.05). Conclusion Sintilimab combined with paclitaxel liposome and cisplatin can significantly increase the success rate of conversion therapy, improve the short-term curative effect and long-term survival of patients with locally advanced unresectable ESCC, and it has good safety.
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