Article(id=1292130294484726675, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.05.007, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1768147200000, receivedDateStr=2026-01-12, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997468824, onlineDateStr=2026-08-06, pubDate=1773676800000, pubDateStr=2026-03-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997468824, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997468824, creator=13701087609, updateTime=1785997468824, updator=13701087609, issue=Issue{id=1292130254689165893, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='5', pageStart='601', pageEnd='750', issueExtLink='null', onlineDate='null', pubDate='1773676800000', pubDateStr='2026-03-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997459337, creator='13701087609', updateTime=1786014469153, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201599108141219, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201599108141220, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=636, endPage=642, ext={EN=ArticleExt(id=1292130295805932436, articleId=1292130294484726675, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical study on the first-line treatment of advanced gastric signet ring cell carcinoma with tislelizumab or sintilimab combined with XELOX regimen, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the clinical efficacy and safety of programmed death-1 (PD-1) inhibitors (tislelizumab injection or sintilimab injection) combined with the capecitabine tablet and oxaliplatin for injection regimen (XELOX) as first-line treatment in patients with advanced gastric signet-ring cell carcinoma (SRCC)

Methods

Patients with SRCC were enrolled and divided into control group and treatment group using a random number table. The control group received the XELOX regimen, 130 mg·m-2 intravenous oxaliplatin for injection on day 1, and oral 1 000 mg·m-2 capecitabine tablets twice daily from days 1 to 14, repeated every 21 days. The treatment group received an intravenous infusion of tislelizumab injection or sintilimab injection 200 mg per dose prior to the XELOX regimen, also administered every 21 days. Both groups were treated for 6 cycles. Clinical efficacy, tumor markers, immune function, clinical scores, safety and long-term prognosis were compared between the two groups.

Results

A total of 82 patients were included, with 41 cases in each group. The levels of carcinoembryonic antigen (CEA) in treatment and control group were (6.46±1.03) and (7.00±0.94) ng·mL-1, respectively; the levels of carbohydrate antigen 19-9 (CA19-9) were (18.62±3.36) and (20.58±3.52) U·mL-1, respectively; vascular endothelial growth factor (VEGF) were (33.57±5.56) and (36.15±5.03) ng·mL-1, respectively; CD3+ T cells were (62.31±5.71)% and (59.50±6.10)%, respectively; CD4+ T cells were (47.56±5.93)% and (44.91±4.84)%, respectively; European organisation for research and treatment of cancer quality of life questionnaire core 30 (QLQ-C30) score were (60.15±11.01) and (55.02±9.46) points, respectively; and revised piper fatigue scale (RPFS) score were (5.05±0.89) and (5.49±0.84) points, respectively; the levels of CA72-4 were (34.07±3.74) and (36.23±3.01) U·mL-1, respectively; the CD4+/CD8+ ratios were 1.99±0.35 and 1.75±0.37, respectively; the differences of above indicators between two groups were all statistically significant (P<0.05, P<0.01). Adverse drug reactions in both groups were gradeⅠorⅡand resolved after drug discontinuation. The incidence of adrenal dysfunction in the treatment group was 14.63% (6 cases/41 cases), which was significantly higher than that in the control group (0%) (P<0.05). The median survival time was 38 months in the treatment group and 28 months in the control group (P<0.05).

Conclusion

PD-1 inhibitors (tislelizumab or sintilimab injection) combined with the XELOX regimen as first-line therapy can enhance the efficacy in patients with advanced SRCC, significantly improve quality of life and long-term survival benefits, and exhibit a favorable safety profile. This therapeutic advantage may be attributed to the regimen’s effect on downregulating tumor markers and improving immune function.

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目的

观察程序性死亡蛋白-1(PD-1)抑制剂(替雷利珠单抗注射液或信迪利单抗注射液)联合卡培他滨片和注射用奥沙利铂方案(XELOX)一线治疗晚期胃印戒细胞癌(SRCC)患者的临床疗效并进行安全性评价。

方法

将我院收治的SRCC患者按照随机数表法分为试验组和对照组。对照组患者给予XELOX方案:第1天,静脉注射注射用奥沙利铂130 mg·m-2,第1~14天口服卡培他滨片1 000 mg·m-2bid;每21 d重复;试验组于XELOX方案前静脉输注替雷利珠单抗注射液或信迪利单抗注射液,每次200 mg,每21 d给药1次,2组均治疗6个周期。比较2组临床疗效、肿瘤标志物、免疫功能、临床评分、安全性及远期预后。

结果

共纳入82例患者,对照组和试验组各41例。试验组和对照组的癌胚抗原(CEA)分别为(6.46±1.03)和(7.00±0.94)ng·mL-1,糖类抗原(CA)19-9分别为(18.62±3.36)和(20.58±3.52)U·mL-1,血管内皮生长因子(VEGF)分别为(33.57±5.56)和(36.15±5.03)ng·mL-1,CD3+分别为(62.31±5.71)和(59.50±6.10)%,CD4+分别为(47.56±5.93)和(44.91±4.84)%,欧洲癌症研究与治疗组织生活质量核心量表(QLQ-C30)评分分别为(60.15±11.01)和(55.02±9.46)分,Piper疲乏量表(RPFS)评分分别为(5.05±0.89)和(5.49±0.84)分,CA 72-4分别为(34.07±3.74)和(36.23±3.01)U·mL-1,CD4+/CD8+分别为1.99±0.35和1.75±0.37,上述指标在2组间比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。2组的药物不良反应均为Ⅰ、Ⅱ级,停药后缓解,试验组肾上腺功能异常发生率14.63%(6例/41例)显著高于对照组的0%(P<0.05)。试验组和对照组的中位生存期分别为38和28个月(P<0.05)。

结论

PD-1抑制剂(替雷利珠单抗或信迪利单抗)联合XELOX方案一线治疗可以提升晚期SRCC患者疗效,显著改善生活质量及长期生存获益,且安全性良好,这一获益优势可能源于联合方案对肿瘤标志物的下调及对机体免疫功能的改善效应。

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张煌(1982-),男,副主任医师,主要从事恶性肿瘤综合治疗的工作和研究

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余嘉文,主任医师,硕士生导师 MP: 13866008030 E-mail:
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替雷利珠单抗或信迪利单抗联合XELOX方案一线治疗晚期胃印戒细胞癌的临床研究
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张煌 , 余嘉文 , 郑华理 , 刘伟
中国临床药理学杂志 | 临床与基础桥接研究 2026,42(5): 636-642
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中国临床药理学杂志 |临床与基础桥接研究 2026 , 42 (5) : 636 -642
替雷利珠单抗或信迪利单抗联合XELOX方案一线治疗晚期胃印戒细胞癌的临床研究
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张煌, 余嘉文 , 郑华理, 刘伟
作者信息
  • 安庆市第一人民医院 肿瘤与血液内科,安徽 安庆 246000
通讯作者:
余嘉文,主任医师,硕士生导师 MP: 13866008030 E-mail:
作者简介:

张煌(1982-),男,副主任医师,主要从事恶性肿瘤综合治疗的工作和研究

Clinical study on the first-line treatment of advanced gastric signet ring cell carcinoma with tislelizumab or sintilimab combined with XELOX regimen
Huang ZHANG, Jia-wen YU , Hua-li ZHENG, Wei LIU
Affiliations
  • Department of Oncology and Hematology, Anqing First People’s Hospital, Anqing 246000, Anhui Province, China
出版时间: 2026-03-17 doi: 10.13699/j.cnki.1001-6821.2026.05.007
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目的

观察程序性死亡蛋白-1(PD-1)抑制剂(替雷利珠单抗注射液或信迪利单抗注射液)联合卡培他滨片和注射用奥沙利铂方案(XELOX)一线治疗晚期胃印戒细胞癌(SRCC)患者的临床疗效并进行安全性评价。

方法

将我院收治的SRCC患者按照随机数表法分为试验组和对照组。对照组患者给予XELOX方案:第1天,静脉注射注射用奥沙利铂130 mg·m-2,第1~14天口服卡培他滨片1 000 mg·m-2bid;每21 d重复;试验组于XELOX方案前静脉输注替雷利珠单抗注射液或信迪利单抗注射液,每次200 mg,每21 d给药1次,2组均治疗6个周期。比较2组临床疗效、肿瘤标志物、免疫功能、临床评分、安全性及远期预后。

结果

共纳入82例患者,对照组和试验组各41例。试验组和对照组的癌胚抗原(CEA)分别为(6.46±1.03)和(7.00±0.94)ng·mL-1,糖类抗原(CA)19-9分别为(18.62±3.36)和(20.58±3.52)U·mL-1,血管内皮生长因子(VEGF)分别为(33.57±5.56)和(36.15±5.03)ng·mL-1,CD3+分别为(62.31±5.71)和(59.50±6.10)%,CD4+分别为(47.56±5.93)和(44.91±4.84)%,欧洲癌症研究与治疗组织生活质量核心量表(QLQ-C30)评分分别为(60.15±11.01)和(55.02±9.46)分,Piper疲乏量表(RPFS)评分分别为(5.05±0.89)和(5.49±0.84)分,CA 72-4分别为(34.07±3.74)和(36.23±3.01)U·mL-1,CD4+/CD8+分别为1.99±0.35和1.75±0.37,上述指标在2组间比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。2组的药物不良反应均为Ⅰ、Ⅱ级,停药后缓解,试验组肾上腺功能异常发生率14.63%(6例/41例)显著高于对照组的0%(P<0.05)。试验组和对照组的中位生存期分别为38和28个月(P<0.05)。

结论

PD-1抑制剂(替雷利珠单抗或信迪利单抗)联合XELOX方案一线治疗可以提升晚期SRCC患者疗效,显著改善生活质量及长期生存获益,且安全性良好,这一获益优势可能源于联合方案对肿瘤标志物的下调及对机体免疫功能的改善效应。

替雷利珠单抗注射液  /  信迪利单抗注射液  /  卡培他滨片联合注射用奥沙利铂方案  /  胃印戒细胞癌  /  程序性死亡蛋白-1抑制剂  /  一线治疗
Objective

To observe the clinical efficacy and safety of programmed death-1 (PD-1) inhibitors (tislelizumab injection or sintilimab injection) combined with the capecitabine tablet and oxaliplatin for injection regimen (XELOX) as first-line treatment in patients with advanced gastric signet-ring cell carcinoma (SRCC)

Methods

Patients with SRCC were enrolled and divided into control group and treatment group using a random number table. The control group received the XELOX regimen, 130 mg·m-2 intravenous oxaliplatin for injection on day 1, and oral 1 000 mg·m-2 capecitabine tablets twice daily from days 1 to 14, repeated every 21 days. The treatment group received an intravenous infusion of tislelizumab injection or sintilimab injection 200 mg per dose prior to the XELOX regimen, also administered every 21 days. Both groups were treated for 6 cycles. Clinical efficacy, tumor markers, immune function, clinical scores, safety and long-term prognosis were compared between the two groups.

Results

A total of 82 patients were included, with 41 cases in each group. The levels of carcinoembryonic antigen (CEA) in treatment and control group were (6.46±1.03) and (7.00±0.94) ng·mL-1, respectively; the levels of carbohydrate antigen 19-9 (CA19-9) were (18.62±3.36) and (20.58±3.52) U·mL-1, respectively; vascular endothelial growth factor (VEGF) were (33.57±5.56) and (36.15±5.03) ng·mL-1, respectively; CD3+ T cells were (62.31±5.71)% and (59.50±6.10)%, respectively; CD4+ T cells were (47.56±5.93)% and (44.91±4.84)%, respectively; European organisation for research and treatment of cancer quality of life questionnaire core 30 (QLQ-C30) score were (60.15±11.01) and (55.02±9.46) points, respectively; and revised piper fatigue scale (RPFS) score were (5.05±0.89) and (5.49±0.84) points, respectively; the levels of CA72-4 were (34.07±3.74) and (36.23±3.01) U·mL-1, respectively; the CD4+/CD8+ ratios were 1.99±0.35 and 1.75±0.37, respectively; the differences of above indicators between two groups were all statistically significant (P<0.05, P<0.01). Adverse drug reactions in both groups were gradeⅠorⅡand resolved after drug discontinuation. The incidence of adrenal dysfunction in the treatment group was 14.63% (6 cases/41 cases), which was significantly higher than that in the control group (0%) (P<0.05). The median survival time was 38 months in the treatment group and 28 months in the control group (P<0.05).

Conclusion

PD-1 inhibitors (tislelizumab or sintilimab injection) combined with the XELOX regimen as first-line therapy can enhance the efficacy in patients with advanced SRCC, significantly improve quality of life and long-term survival benefits, and exhibit a favorable safety profile. This therapeutic advantage may be attributed to the regimen’s effect on downregulating tumor markers and improving immune function.

tislelizumab injection  /  sintilimab injection  /  capecitabine tablet plus oxaliplatin for injection  /  gastric signet ring cell carcinoma  /  programmed death-1 inhibitor  /  first-line treatment
张煌, 余嘉文, 郑华理, 刘伟. 替雷利珠单抗或信迪利单抗联合XELOX方案一线治疗晚期胃印戒细胞癌的临床研究. 中国临床药理学杂志, 2026 , 42 (5) : 636 -642 . DOI: 10.13699/j.cnki.1001-6821.2026.05.007
Huang ZHANG, Jia-wen YU, Hua-li ZHENG, Wei LIU. Clinical study on the first-line treatment of advanced gastric signet ring cell carcinoma with tislelizumab or sintilimab combined with XELOX regimen[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (5) : 636 -642 . DOI: 10.13699/j.cnki.1001-6821.2026.05.007

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doi: 10.13699/j.cnki.1001-6821.2026.05.007
  • 接收时间:2026-01-12
  • 首发时间:2026-08-06
  • 出版时间:2026-03-17
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  • 收稿日期:2026-01-12
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    安庆市第一人民医院 肿瘤与血液内科,安徽 安庆 246000

通讯作者:

余嘉文,主任医师,硕士生导师 MP: 13866008030 E-mail:
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
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