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

doi:10.3969/j.issn.1006-5725.2026.06.010

Abstract

Abstract:

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.

Key words: esophageal squamous cell carcinoma, unresectable locally advanced stage, sintilimab, TP regimen, success rate of conversion therapy, survival rate

CLC Number:

R735.1

Chen NI,Shaokai WANG,Yu SONG,Chenjie TAO,Jian JIANG,Zhipeng CHEN,Huiping ZHU. Sintilimab combined with chemotherapy for unresectable locally advanced ESCC： An analysis of efficacy and prognosis[J]. The Journal of Practical Medicine, 2026, 42(6): 981-990.

Figures/Tables 6

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References 30

[1]	MORGAN E， SOERJOMATARAM I， RUMGAY H， et al. The global landscape of esophageal squamous cell carcinoma and esophageal adenocarcinoma incidence and mortality in 2020 and projections to 2040： New estimates from GLOBOCAN 2020［J］. Gastroenterology， 2022， 163（3）： 649-658.e2. doi：10.1053/j.gastro.2022.05.054 . doi: 10.1053/j.gastro.2022.05.054
[2]	LANDER S， LANDER E， GIBSON M K. Esophageal cancer： Overview， risk factors， and reasons for the rise［J］. Curr Gastroenterol Rep， 2023， 25（11）： 275-279. doi：10.1007/s11894-023-00899-0 . doi: 10.1007/s11894-023-00899-0
[3]	刘良忠，李小红，彭科瑜，等. 调强放疗同步多西他赛联合奥沙利铂化疗治疗Ⅲ/Ⅳ期食管癌的临床研究［J］. 实用医学杂志， 2019， 35（24）： 3808-3812. doi：10.3969/j.issn.1006-5725.2019.24.017 . doi: 10.3969/j.issn.1006-5725.2019.24.017
[4]	TESTA U， CASTELLI G， PELOSI E. The molecular characterization of genetic abnormalities in esophageal squamous cell carcinoma may foster the development of targeted therapies［J］. Curr Oncol， 2023， 30（1）： 610-640. doi：10.3390/curroncol30010048 . doi: 10.3390/curroncol30010048
[5]	TANCOŠ V， BLICHÁROVÁ A， PLANK L. Programmed death-ligand 1 expression in non-small cell lung carcinoma-Mechanism of regulation， association with other markers， and therapeutic implication［J］. Klin Onkol， 2022， 35（5）： 372-376. doi：10.48095/ccko2022372 . doi: 10.48095/ccko2022372
[6]	WOODARD G A， CHO C， CHEN L. Could programmed death-ligand 1 copy number alterations be a predictive biomarker for immunotherapy response？［J］. J Thorac Oncol， 2022， 17（5）： 592-595. doi：10.1016/j.jtho.2022.03.009 . doi: 10.1016/j.jtho.2022.03.009
[7]	LU S， WU L， JIAN H， et al. Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy （ORIENT-31）： Second interim analysis from a double-blind， randomised， placebo-controlled， phase 3 trial［J］. Lancet Respir Med， 2023， 11（7）： 624-636. doi：10.1016/s2213-2600（23）00135-2 . doi: 10.1016/s2213-2600（23）00135-2
[8]	REN Z， XU J， BAI Y， et al. Sintilimab plus a bevacizumab biosimilar （IBI₃05） versus sorafenib in unresectable hepatocellular carcinoma （ORIENT-32）： A randomised， open-label， phase 2–3 study［J］. Lancet Oncol， 2021， 22（7）： 977-990. doi：10.1016/s1470-2045（21）00252-7 . doi: 10.1016/s1470-2045（21）00252-7
[9]	LIU X， ZHANG Y， YANG K Y， et al. Induction-concurrent chemoradiotherapy with or without sintilimab in patients with locoregionally advanced nasopharyngeal carcinoma in China （CONTINUUM）： A multicentre， open-label， parallel-group， randomised， controlled， phase 3 trial［J］. Lancet， 2024， 403（10445）： 2720-2731. doi：10.1016/s0140-6736（24）00594-4 . doi: 10.1016/s0140-6736（24）00594-4
[10]	ZHOU C， WU L， FAN Y， et al. Sintilimab plus platinum and gemcitabine as first-line treatment for advanced or metastatic squamous NSCLC： Results from a randomized， double-blind， phase 3 trial （ORIENT-12）［J］. J Thorac Oncol， 2021， 16（9）： 1501-1511. doi：10.1016/j.jtho.2021.04.011 . doi: 10.1016/j.jtho.2021.04.011
[11]	HANAOKA M， HINO H， SHIOMI A， et al. The Eastern Cooperative Oncology Group Performance Status as a prognostic factor of stage Ⅰ-Ⅲ colorectal cancer surgery for elderly patients： A multi-institutional retrospective analysis［J］. Surg Today， 2022， 52（7）： 1081-1089. doi：10.1007/s00595-021-02412-4 . doi: 10.1007/s00595-021-02412-4
[12]	中国食管癌筛查与早诊早治指南制定专家组.中国食管癌筛查与早诊早治指南（2022）［J］. 中华消化外科杂志， 2022， 21（6）： 677-700. doi：10.3760/cma.j.cn112152-20220517-00348 . doi: 10.3760/cma.j.cn112152-20220517-00348
[13]	SCHWARTZ L H， SEYMOUR L， LITIÈRE S， et al. RECIST 1.1-Standardisation and disease-specific adaptations： Perspectives from the RECIST Working Group［J］. Eur J Cancer， 2016， 62： 138-145. doi：10.1016/j.ejca.2016.03.082 . doi: 10.1016/j.ejca.2016.03.082
[14]	WALIA A， TUIA J， PRASAD V. Progression-free survival， disease-free survival and other composite end points in oncology： Improved reporting is needed［J］. Nat Rev Clin Oncol， 2023， 20（12）： 885-895. doi：10.1038/s41571-023-00823-5 . doi: 10.1038/s41571-023-00823-5
[15]	江汝伟，黄思宇.食管鳞癌组织中IRF4，MDM2，C-myc表达与预后的关系研究［J］.转化医学杂志， 2024， 13（7）：1005-1009. doi：10.3969/j.issn.2095-3097.2024.07.005 . doi: 10.3969/j.issn.2095-3097.2024.07.005
[16]	张婷婷，刘克，陈丹，等.帕博利珠单抗加小剂量阿帕替尼联合治疗老年食管癌的有效性及安全性［J］.实用医学杂志， 2024， 40（24）：3534-3538. doi：10.3969/j.issn.1006-5725.2024.24.016 . doi: 10.3969/j.issn.1006-5725.2024.24.016
[17]	LIU Z， ZHAO Y， KONG P， et al. Integrated multi-omics profiling yields a clinically relevant molecular classification for esophageal squamous cell carcinoma［J］. Cancer Cell，2023，41（1）：181-195. doi：10.1016/j.ccell.2022.12.004 . doi: 10.1016/j.ccell.2022.12.004
[18]	CHENG N， WANG H， ZOU M， et al. Brain-derived programmed death-ligand 1 mediates immunosuppression post intracerebral hemorrhage［J］. J Cereb Blood Flow Metab， 2022， 42（11）： 2048-2057. doi：10.1177/0271678x221116048 . doi: 10.1177/0271678x221116048
[19]	MONSRUD A L， AVADHANI V， MOSUNJAC M B， et al. Programmed death ligand-1 expression is associated with poorer survival in anal squamous cell carcinoma［J］. Arch Pathol Lab Med， 2022， 146（9）： 1094-1101. doi：10.5858/arpa.2021-0169-oa . doi: 10.5858/arpa.2021-0169-oa
[20]	岳瑞雪，胡崇珠，郝鑫，等.曲妥珠单抗和帕妥珠单抗联合不同化疗方案新辅助治疗HER-2阳性乳腺癌真实世界疗效及安全性观察［J］.中国肿瘤临床， 2023， 50（5）： 248-254. doi：10.12354/j.issn.1000-8179.2023.20221276 . doi: 10.12354/j.issn.1000-8179.2023.20221276
[21]	耿嘉懿，慕腾，赵恒，等.食管鳞状细胞癌新辅助免疫治疗联合化疗后手术间隔时间对病理学结局和预后的影响［J］.中华外科杂志， 2025， 63（7）：597-604. doi：10.3760/cma.j.cn112139-20241121-00523 . doi: 10.3760/cma.j.cn112139-20241121-00523
[22]	刘倩，王蕾，陆叶，等.拉帕替尼联合化疗治疗中晚期食管癌的效果及安全性［J］.肿瘤研究与临床， 2025， 37（8）： 618-622. doi：10.3760/cma.j.cn115355-20240621-00305 . doi: 10.3760/cma.j.cn115355-20240621-00305
[23]	轩周莎莎，张学强，杨晨，等.食管癌患者卡瑞利珠单抗治疗前后血清KLF4，ANXA1水平变化及对疾病转归的交互作用分析［J］.实用药物与临床， 2024， 27（9）：655-660. doi：10.14053/j.cnki.ppcr.202409003 . doi: 10.14053/j.cnki.ppcr.202409003
[24]	CHEN X， XU X， WANG D， et al. Neoadjuvant sintilimab and chemotherapy in patients with potentially resectable esophageal squamous cell carcinoma （KEEP-G 03）： An open-label， single-arm， phase 2 trial［J］. J Immunother Cancer， 2023， 11（2）： e005830. doi：10.1136/jitc-2022-005830 . doi: 10.1136/jitc-2022-005830
[25]	XU J， LI Y， FAN Q， et al. Clinical and biomarker analyses of sintilimab versus chemotherapy as second-line therapy for advanced or metastatic esophageal squamous cell carcinoma： A randomized， open-label phase 2 study （ORIENT-2）［J］. Nat Commun， 2022， 13： 857. doi：10.1038/s41467-022-28408-3 . doi: 10.1038/s41467-022-28408-3
[26]	宋芬芬，李胜棉.基于卡瑞利珠单抗的方案治疗局部晚期及转移性食管癌的真实世界研究［J］.中国全科医学， 2025， 28（7）：844-852. doi：10.12114/j.issn.1007-9572.2023.0448 . doi: 10.12114/j.issn.1007-9572.2023.0448
[27]	WANG R， GUO T， WANG Q， et al. The efficacy and safety of induction chemotherapy combined with sintilimab followed by concurrent chemoradiotherapy plus sintilimab sequencing maintaining with sintilimab for patients with unresectable locally advanced esophageal squamous cell carcinoma［J］. BMC Cancer， 2025， 25（1）： 97. doi：10.1186/s12885-025-13457-w . doi: 10.1186/s12885-025-13457-w
[28]	CUI S， FAN L， SUN X， et al. Recombinant human-endostatin combined with sintilimab and chemotherapy in first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma［J］. Oncol Lett， 2025， 29（5）： 244. doi：10.3892/ol.2025.14990 . doi: 10.3892/ol.2025.14990
[29]	王豪，陆筱祎，王文杰. 老年局部晚期食管癌同步放化疗序贯信迪利单抗免疫治疗的疗效［J］. 实用医学杂志， 2025， 41（3）： 365-370. doi：10.3969/j.issn.1006-5725.2025.03.009 . doi: 10.3969/j.issn.1006-5725.2025.03.009
[30]	王献，尚自强，杨冬，等. 食管癌患者外周血中白细胞介素-1β和组织中程序性死亡分子1的表达对预后的影响及临床意义［J］.中国医科大学学报， 2023， 52（12）： 1082-1086. doi：10.12007/j.issn.0258-4646.2023.12.005 . doi: 10.12007/j.issn.0258-4646.2023.12.005

项目	联合组（n = 53）	对照组（n = 29）	t/χ²值	P值
年龄（x ± s）/岁	62.35 ± 5.80	63.12 ± 6.04	0.566	0.573
BMI（x ± s）/（kg/m²）	20.89 ± 0.75	21.03 ± 0.81	0.786	0.434
性别
男	47（88.68）	25（86.21）	0.107	0.744
女	6（11.32）	4（13.79）
肿瘤原发部位
胸上段	8（15.09）	4（13.79）	0.037	0.982
胸中段	24（45.28）	13（44.83）
胸下段	21（39.62）	12（41.38）
TNM分期
ⅢB期	29（54.72）	16（55.17）	0.002	0.968
ⅢC期	24（45.28）	13（44.83）
分化程度
低分化	28（52.83）	14（48.28）	0.156	0.693
中高分化	25（47.17）	15（51.72）
手术后病理分期（ypTNM分期）
Ⅰ期	3（5.66）	0（0.00）	5.850	0.119
ⅡA期	9（16.98）	1（3.45）
ⅡB期	7（13.21）	3（10.34）
无（未转化成功）	34（64.15）	25（86.21）

组别	例数	CR	PR	SD	PD	ORR	DCR
联合组	53	0（0.00）	32（60.38）	15（28.30）	6（11.32）	32（60.38）	47（88.68）
对照组	29	0（0.00）	10（34.48）	10（34.48）	9（31.03）	10（34.48）	20（68.97）
χ²值						5.030	4.874
P值						0.025	0.027

组别	例数	SCC-Ag		CEA		CYFRA 21-1
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
联合组	53	3.12 ± 0.34	1.01 ± 0.16^*	5.51 ± 0.20	1.62±0.18^*	3.59 ± 0.38	1.12 ± 0.14^*
对照组	29	3.20 ± 0.41	1.75 ± 0.23^*	5.58 ± 0.39	2.47±0.22^*	3.67 ± 0.41	1.79 ± 0.28^*
t值		0.946	17.087	1.243	18.878	0.886	14.471
P值		0.347	< 0.001	0.217	< 0.001	0.378	< 0.001

组别	例数	PD-1		PD-L1
组别	例数	治疗前	治疗后	治疗前	治疗后
联合组	53	29.15 ± 4.62	13.28 ± 3.25	12.68 ± 5.34	4.12 ± 0.75
对照组	29	28.76 ± 4.81	21.54 ± 3.79	13.12 ± 5.60	7.85 ± 1.92
t值		0.360	10.370	0.351	12.549
P值		0.720	< 0.001	0.727	< 0.001

组别	例数	骨髓抑制			肝肾功能损害
组别	例数	Ⅲ级	Ⅳ级	总发生率	Ⅱ级	Ⅲ—Ⅳ级	总发生率
联合组	53	12（22.64）	2（3.77）	14（26.42）	2（3.77）	0（0.00）	2（3.77）
对照组	29	6（20.69）	1（3.45）	7（24.14）	1（3.45）	1（3.45）	2（6.90）
χ²值				0.051			0.394
P值				0.821			0.530
组别	例数	胃肠道不适			皮疹
组别	例数	Ⅰ—Ⅱ级	Ⅲ—Ⅳ级	总发生率	Ⅰ—Ⅱ级	Ⅲ—Ⅳ级	总发生率
联合组	53	17（32.08）	3（5.66）	20（37.74）	4（7.55）	1（1.89）	5（9.43）
对照组	29	8（27.59）	2（6.90）	10（34.48）	0（0.00）	2（6.90）	2（6.90）
χ²值				0.085			0.316
P值				0.770			0.712

Sintilimab combined with chemotherapy for unresectable locally advanced ESCC： An analysis of efficacy and prognosis

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