PD-1/PD-L1抑制剂联合化疗一线治疗晚期胆道恶性肿瘤的疗效及安全性研究

doi:10.12092/j.issn.1009-2501.2026.08.008

中国临床药理学与治疗学 ›› 2026, Vol. 31 ›› Issue (8): 1076-1084.doi: 10.12092/j.issn.1009-2501.2026.08.008

• 药物治疗学 • 上一篇

PD-1/PD-L1抑制剂联合化疗一线治疗晚期胆道恶性肿瘤的疗效及安全性研究

王荣¹(), 周昳欣¹, 薛璟¹, 郝吉庆¹, 黄帆², 邢江浩¹^,*()

1. 安徽医科大学第一附属医院肿瘤内科，合肥 230022，安徽
2. 安徽医科大学第一附属医院肝胆外科，合肥 230022，安徽

收稿日期:2025-06-04 修回日期:2025-09-16 出版日期:2026-08-26 发布日期:2026-09-09
通讯作者: 邢江浩 E-mail:wr_roral@163.com;jianghaoxing@ahmu.edu.cn
作者简介:王荣，女，硕士，主治医师，研究方向：肿瘤免疫。E-mail：wr_roral@163.com
基金资助:
白求恩·精医求精-晚期实体瘤科研项目（STLKY2-140）；2022年安徽省临床医学研究转化专项项目（202204295107020016）

Efficacy and safety of PD-1/PD-L1 inhibitors combined with chemotherapy in the treatment of advanced biliary malignancies in the first line of chemotherapy

Rong WANG¹(), Yixin ZHOU¹, Jing XUE¹, Jiqing HAO¹, Fan HUANG², Jianghao XING¹^,*()

1. Department of Oncology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, Anhui, China
2. Department of Hepatobiliary Surgery, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, Anhui, China

Received:2025-06-04 Revised:2025-09-16 Online:2026-08-26 Published:2026-09-09
Contact: Jianghao XING E-mail:wr_roral@163.com;jianghaoxing@ahmu.edu.cn

摘要/Abstract

摘要：

目的: 探索程序性细胞死亡蛋白-1/其配体-1（programmed cell death protein-1/its ligand-1，PD-1/ PD-L1）抑制剂联合化疗一线治疗晚期胆道恶性肿瘤的疗效及安全性。方法: 回顾性收集2020年8月至2022年8月安徽医科大学第一附属医院收治的33例经组织病理学确诊的晚期胆道恶性肿瘤患者，根据一线治疗中是否应用PD-1/PD-L1抑制剂分为常规化疗组和联合免疫治疗组，每2周期进行疗效评价，每周期评价安全性，主要研究终点为无进展生存期（progression-free survival，PFS），次要终点为治疗的安全性。结果: 33例患者无完全缓解（complete response，CR）病例，常规化疗组16例患者，其中部分缓解（partial response，PR）3例、疾病稳定（stable disease，SD）6例、疾病进展（progressive disease，PD）7例，客观有效率（objective response rate，ORR）为18.8%，疾病控制率（disease control rate，DCR）为56.2%。中位PFS为13.1周。联合免疫治疗组17例患者，其中PR 8例、SD 5例、PD 4例，ORR为47.1%，DCR为76.5%，中位PFS为21.9周，优于常规化疗组，且差异具有统计学意义。两组不良反应多为1-2级，可耐受，差异均无统计学意义。结论: PD-1/PD-L1抑制剂联合化疗和/或抗血管药物治疗晚期胆道恶性肿瘤疗效确切，安全性良好，PD-1/PD-L1抑制剂联合化疗治疗晚期胆道恶性肿瘤的治疗模式值得临床进一步探索。

关键词: 晚期胆道恶性肿瘤, 免疫检查点抑制剂, 化疗, PD-1/PD-L1

Abstract:

AIM: To explore the efficacy and safety of programmed cell death protein-1/its ligand-1 (PD-1/PD-L1) inhibitors combined with chemotherapy in the treatment of advanced biliary malignancies in the first line of chemotherapy. METHODS: A retrospective collection of 33 patients with advanced biliary malignant tumors confirmed by histopathology in the First Affiliated Hospital of Anhui Medical University from August 2020 to August 2022 were retrospectively collected, and they were divided into chemotherapy group and chemotherapy combined with PD-1/PD-L1 inhibitor group, and the efficacy was evaluated every 2 treatment cycles, and the safety was evaluated every cycle. The first outcome is PFS and the secondary endpoint is the safety of treatment. RESULTS: Among 16 patients in the chemotherapy group, there were 3 PR cases, 6 SD cases and 7 PD cases, with an ORR rate of 18.8% and a DCR rate of 56.2%. The median PFS was 13.1 weeks. Among 17 patients in the immunotherapy group, there were 8 PR cases, 5 SD cases and 4 PD cases. The ORR rate was 47.1%, the DCR rate was 76.5%, and the median PFS was 21.9 weeks, which was better than the chemotherapy alone. Most of the adverse effects in the two groups were 1-2 grade tolerable, and the difference was not statistically significant. CONCLUSION: PD-1/PD-L1 inhibitors combined with chemotherapy and/or anti-vascular drugs for advanced biliary malignancies have a definite efficacy and is safety, and the treatment with PD-1/PD-L1 inhibitors combined with chemotherapy for advanced biliary malignancies deserves further clinical exploration.

Key words: advanced biliary malignancies, Immune checkpoint inhibitors, chemotherapy, PD-1/PD-L1

中图分类号:

王荣, 周昳欣, 薛璟, 郝吉庆, 黄帆, 邢江浩. PD-1/PD-L1抑制剂联合化疗一线治疗晚期胆道恶性肿瘤的疗效及安全性研究[J]. 中国临床药理学与治疗学, 2026, 31(8): 1076-1084.

Rong WANG, Yixin ZHOU, Jing XUE, Jiqing HAO, Fan HUANG, Jianghao XING. Efficacy and safety of PD-1/PD-L1 inhibitors combined with chemotherapy in the treatment of advanced biliary malignancies in the first line of chemotherapy[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2026, 31(8): 1076-1084.

图/表 5

参考文献 29

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Item	Chemotherapy (n=16)	Chemotherapy combined with immunotherapy (n=17)	P-value
Gender
Male	7 (43.8%)	12 (70.6%)	0.228
Female	9 (56.3%)	5 (29.4%)
Years
Mean (SD)	59.4 (9.59)	57.8 (7.72)	0.601
Median[Min, Max]	57.5 [42.0, 75.0]	57.0 [45.0, 71.0]
Tumor type
Gallbladder cancer	6 (37.5%)	5 (29.4%)	0.902
Cholangiocarcinoma	10 (62.5%)	12 (70.6%)
Tumor grade
Poorly differentiated	5 (31.3%)	6 (35.3%)	1
Moderately differentiated	11 (68.8%)	11 (64.7%)
MSS
Stable	4 (25.0%)	4 (23.5%)	1
Unclear	12 (75.0%)	13 (76.5%)
Follow-up time (weeks)
Mean(SD)	41.4 (23.9)	35.4 (15.9)	0.41
Median[Min, Max]	39.5 [10.3, 96.6]	30.1 [12.4, 69.4]

Item	Chemotherapy (n=16)	Chemotherapy combined with immunotherapy (n=17)	P-value
Gender
Male	7 (43.8%)	12 (70.6%)	0.228
Female	9 (56.3%)	5 (29.4%)
Years
Mean (SD)	59.4 (9.59)	57.8 (7.72)	0.601
Median[Min, Max]	57.5 [42.0, 75.0]	57.0 [45.0, 71.0]
Tumor type
Gallbladder cancer	6 (37.5%)	5 (29.4%)	0.902
Cholangiocarcinoma	10 (62.5%)	12 (70.6%)
Tumor grade
Poorly differentiated	5 (31.3%)	6 (35.3%)	1
Moderately differentiated	11 (68.8%)	11 (64.7%)
MSS
Stable	4 (25.0%)	4 (23.5%)	1
Unclear	12 (75.0%)	13 (76.5%)
Follow-up time (weeks)
Mean(SD)	41.4 (23.9)	35.4 (15.9)	0.41
Median[Min, Max]	39.5 [10.3, 96.6]	30.1 [12.4, 69.4]

Item	Chemotherapy (n=16)	Chemotherapy combined with immunotherapy (n=17)	P-value
PR
No	13 (81.3%)	9 (52.9%)	0.176
Yes	3 (18.8%)	8 (47.1%)
SD
No	10 (62.5%)	12 (70.6%)	0.902
Yes	6 (37.5%)	5 (29.4%)
PD
No	9 (56.3%)	13 (76.5%)	0.389
Yes	7 (43.8%)	4 (23.5%)
DCR	9 (56.2%)	13 (76.4%)	0.282
ORR	3 (18.8%)	8 (47.1%)	0.176

Item	Chemotherapy (n=16)	Chemotherapy combined with immunotherapy (n=17)	P-value
PR
No	13 (81.3%)	9 (52.9%)	0.176
Yes	3 (18.8%)	8 (47.1%)
SD
No	10 (62.5%)	12 (70.6%)	0.902
Yes	6 (37.5%)	5 (29.4%)
PD
No	9 (56.3%)	13 (76.5%)	0.389
Yes	7 (43.8%)	4 (23.5%)
DCR	9 (56.2%)	13 (76.4%)	0.282
ORR	3 (18.8%)	8 (47.1%)	0.176

Item		No.	HR (Univariable)	HR (Multivariable)
Treatment	Chemotherapy	16 (48.5%)
	Chemotherapy combined with immunotherapy	17 (51.5%)	0.37 (0.17-0.80, P=0.012)	0.28 (0.11-0.70, P=0.007)
Gender	Male	19 (57.6%)
	Female	14 (42.4%)	1.76 (0.84-3.71, P=0.133)	1.34 (0.52-3.43, P=0.545)
Years		58.5 ± 8.6	0.99 (0.95-1.03, P=0.575)	0.97 (0.93-1.01, P=0.183)
Tumor type	Gallbladder cancer	11 (33.3%)
	Cholangiocarcinoma	22 (66.7%)	1.24 (0.59-2.59, P=0.574)	1.02 (0.46-2.26, P=0.970)
Tumor grade	Poorly differentiated	11 (33.3%)
	Moderately differentiated	22 (66.7%)	2.01 (0.88-4.62, P=0.100)	2.12 (0.82-5.49, P=0.121)
MSI	Stable	8 (24.2%)
	Unclear	25 (75.8%)	0.92 (0.40-2.08, P=0.834)	0.88 (0.37-2.13, P=0.784)

PD-1/PD-L1抑制剂联合化疗一线治疗晚期胆道恶性肿瘤的疗效及安全性研究

Efficacy and safety of PD-1/PD-L1 inhibitors combined with chemotherapy in the treatment of advanced biliary malignancies in the first line of chemotherapy

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参考文献 29

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Adverse event	Chemotherapy group (n=16)	Chemo-immunotherapy group (n=17)	P-value
Emesis
None	7 (43.8%)	8 (47.1%)	0.508
Grade 1	3 (18.8%)	6 (35.3%)
Grade 2	5 (31.3%)	2 (11.8%)
Grade 3	1 (6.3%)	1 (5.9%)
Fatigue
None	6 (37.5%)	7 (41.2%)	0.276
Grade 1	4 (25.0%)	7 (41.2%)
Grade 2	6 (37.5%)	2 (11.8%)
Grade 3	0 (0%)	1 (5.9%)
Neutropenia
None	5 (31.3%)	5 (29.4%)	0.249
Grade 1	5 (31.3%)	9 (52.9%)
Grade 2	3 (18.8%)	0 (0%)
Grade 3	3 (18.8%)	3 (17.6%)
Leukopenia
None	5 (31.3%)	5 (29.4%)	0.249
Grade 1	5 (31.3%)	9 (52.9%)
Grade 2	3 (18.8%)	0 (0%)
Grade 3	3 (18.8%)	3 (17.6%)
Thrombocytopenia
None	7 (43.8%)	7 (41.2%)	0.23
Grade 1	4 (25.0%)	8 (47.1%)
Grade 2	3 (18.8%)	0 (0%)
Grade 3	2 (12.5%)	2 (11.8%)
Rash
None	11 (68.8%)	13 (76.5%)	0.516
Grade 1	4 (25.0%)	3 (17.6%)
Grade 2	1 (6.3%)	0 (0%)
Grade 3	0 (0%)	1 (5.9%)
Immune-related hepatitis
None	16 (100%)	14 (82.4%)	NA
Grade1	0 (0%)	2 (11.8%)
Grade 2	0 (0%)	1 (5.9%)
AST elevated
None	12 (75.0%)	12 (70.6%)	0.681
Grade1	2 (12.5%)	3 (17.6%)
Grade 2	1 (6.3%)	0 (0%)
Grade 3	1 (6.3%)	2 (11.8%)
ALT elevated
None	12 (75.0%)	12 (70.6%)	0.681
Grade 1	2 (12.5%)	3 (17.6%)
Grade 2	1 (6.3%)	0 (0%)
Grade 3	1 (6.3%)	2 (11.8%)
Hand-Foot Syndrome (HFS)
None	14 (87.5%)	15 (88.2%)	0.571
Grade 1	1 (6.3%)	1 (5.9%)
Grade 2	0 (0%)	1 (5.9%)
Grade 3	1 (6.3%)	0 (0%)
Diarrhea
None	15 (93.8%)	15 (88.2%)	NA
Grade 1	1 (6.3%)	1 (5.9%)
Grade 2	0 (0%)	0 (0%)
Grade 3	0 (0%)	1 (5.9%)
Hypertension
None	16 (100%)	13 (76.5%)	0.232
Grade 1	0 (0%)	2 (11.8%)
Grade 2	0 (0%)	1 (5.9%)
Grade 3	0 (0%)	1 (5.9%)
Localized pneumonia
None	16 (100%)	15 (88.2%)	NA
Grade 1	0 (0%)	1 (5.9%)
Grade 2	0 (0%)	1 (5.9%)
Hyperthyroidism
None	16 (100%)	16 (94.1%)	NA
Grade 1	0 (0%)	1 (5.9%)
Myositis
None	16 (100%)	15 (88.2%)	NA
Grade 1	0 (0%)	2 (11.8%)

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