Article(id=1291704934035116411, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.19.003, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1746979200000, receivedDateStr=2025-05-12, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896054990, onlineDateStr=2026-08-05, pubDate=1760630400000, pubDateStr=2025-10-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896054990, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896054990, creator=13701087609, updateTime=1785896054990, updator=13701087609, issue=Issue{id=1291704892859638107, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='19', pageStart='2701', pageEnd='2850', issueExtLink='null', onlineDate='null', pubDate='1760630400000', pubDateStr='2025-10-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896045171, creator='13701087609', updateTime=1785896787712, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708007352656266, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708007352656267, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2711, endPage=2716, ext={EN=ArticleExt(id=1291704934634901884, articleId=1291704934035116411, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical study of sintilimab combined with chemotherapy in patients with advanced gastric cancer, 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 combination of sintilimab injection and chemotherapy on patients with advanced gastric cancer.

Methods

Patients with advanced gastric cancer in gastrointestinal tumor center of the hospital were retrospectively analyzed and divided into control group and treatment group. Control group was given XELOX chemotherapy regimen (intravenous drip of 130 mg·m-2 oxaliplatin injection on the 1st day of each cycle; oral administration of 1 000 mg·m-2 capecitabine tablets in the morning and evening, continuous medication from the 1st day to the 14th day of each cycle, 21 days as a cycle). On the basis of control group, treatment group was given 200 mg of sintilimab injection by intravenous drip on the 1st day of each cycle, and were treated no more than 8 cycles (21 days as a cycle), and received maintenance regimen (control group was given single drug treatment, 1 000 mg·m-2 capecitabine tablets orally in the morning and evening, for 14 consecutive days and 7 days of discontinuation, 21 days as a cycle; on the basis of control group, treatment group was given 200 mg of sintilimab injection, intravenous drip, on the first day of each cycle, 21 days as a cycle) after disease control. The patients were followed up until death. The remission rate, blood markers including matrix metalloproteinase-9 (MMP-9), neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) and survival prognosis were compared between the two groups, and the safety was evaluated.

Results

A total of 86 patients with advanced gastric cancer were selected from the hospital information system. According to the different treatment regimens, they were classified into control group and treatment group, with 43 cases in each group. After excluding those who changed the drug dose or changed the treatment method due to personal reasons during treatment process, 38 cases were included in control group and 42 cases were included in treatment group. After treatment, the levels of MMP-9 in treatment group and control group were (230.74±54.37) and (311.95±69.76) μg·L-1, the NLR were 1.44±0.37 and 1.82±0.47, the PLR were 134.42±17.55 and 162.46±17.17, respectively, and there were statistical significantly differences in the above indexes between treatment group and control group (all P<0.05). The objective remission rates in treatment group and control group were 54.76% (23 cases/42 cases) and 31.58% (12 cases /38 cases), and the disease control rates were 96.83% (40 cases/42 cases) and 78.95% (30 cases/38 cases), respectively, the above indicators in treatment group were statistically significantly different from those in control group (all P<0.05). The median progression-free survival [95% confidence interval (CI)] values in treatment group and control group were 19.00 (95%CI: 16.89-21.11) and 12.00 (95%CI: 12.74-17.26) months, and the median overall survival (95%CI) values were 25.00 (95%CI: 23.78-26.22) and 20.00 (95%CI: 16.98-23.02) months, respectively, the above indicators revealed statistical significantly differences between treatment group and control group (all P<0.05). The incidence rates of myelosuppression in treatment group and control group were 45.24% (19 cases/42 cases) and 60.53% (23 cases/38 cases), and the incidence rates of gastrointestinal reaction were 35.71% (15 cases/42 cases) and 39.47% (15 cases/38 cases), and incidence rates of liver function injury were 26.19% (11 cases/42 cases) and 21.05% (8 cases/38 cases), and the incidence rates of hand-foot syndrome were 21.43% (9 cases/42 cases) and 15.79% (6 cases/38 cases), and the incidence rates of neurotoxicity were 40.48% (17 cases/42 cases) and 52.63% (20 cases/38 cases), and the incidence rates of thyroid dysfunction were 7.14% (3 cases/42 cases) and 0.00% (0 cases/38 cases), respectively, without statistical significantly differences (all P>0.05).

Conclusion

The application of sintilimab injection combined with XELOX chemotherapy regimen in patients with advanced gastric cancer can effectively enhance the remission rate, reduce the levels of serum MMP-9, NLR and PLR, and improve the survival prognosis, with good safety.

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目的

观察信迪利单抗注射液联合化疗对晚期胃癌患者的临床疗效和安全性。

方法

回顾性分析本院胃肠肿瘤中心收治的晚期胃癌患者,按治疗方案分为试验组与对照组,对照组给予XELOX化疗方案(130 mg·m-2奥沙利铂注射液,静脉滴注,每周期第1天给药;1 000 mg·m-2卡培他滨片,早晚口服,每周期第1~14天持续用药,21天为1周期),试验组在对照组基础上给予信迪利单抗注射液200 mg,静脉滴注,每周期第1天给药,21天为1周期,均治疗不超过8个周期,若患者疾病控制后给予维持方案(对照组给予单药治疗,1 000 mg·m-2卡培他滨片早晚口服,连续服用14天,停用7天,21天为1周期;试验组在对照组基础上,给予信迪利单抗注射液200 mg,静脉滴注,每周期第1天给药,21天为1周期)治疗,随访至患者死亡。比较2组患者的缓解率、包括基质金属蛋白酶9(MMP-9)、中性粒细胞与淋巴细胞比值(NLR)血小板与淋巴细胞比值(PLR)在内的血标志物及生存预后,并进行安全性评价。

结果

共纳入晚期胃癌患者86例,根据治疗方案的不同将其分为试验组和对照组,各43例,剔除在治疗过程中因个人原因自行更改药物剂量或更换治疗方法者后,最终对照组共纳入38例,试验组共纳入42例。治疗后,试验组和对照组的MMP-9水平分别为(230.74±54.37)和(311.95±69.76)μg·L-1,NLR分别为1.44±0.37和1.82±0.47,PLR分别为134.42±17.55和162.46±17.17,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(P<0.05)。试验组和对照组患者的客观缓解率分别为54.76%(23例/42例)和31.58%(12例/38例);疾病控制率分别为96.83%(40例/42例)和78.95%(30例/38例),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(P<0.05)。试验组和对照组的中位无进展生存期[95%置信区间(CI)]分别为19.00(16.89~21.11)和12.00(12.74~17.26)个月,中位总生存期(95% CI)分别为25.00(23.78~26.22)和20.00(16.98~23.02)个月,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(P<0.05)。试验组和对照组的药物不良反应中骨髓抑制发生率分别为45.24%(19例/42例)和60.53%(23例/38例),胃肠反应发生率分别为35.71%(15例/42例)和39.47%(15例/38例),肝功能损害发生率分别为26.19%(11例/42例)和21.05%(8例/38例),手足综合征发生率分别为21.43%(9例/42例)和15.79%(6例/38例),神经毒性发生率分别为40.48%(17例/42例)和52.63%(20例/38例),甲状腺功能障碍发生率分别为7.14%(3例/42例)和0.00%(0例/38例),在统计学上差异均无统计学意义(均P>0.05)。

结论

信迪利单抗注射液联合XELOX化疗方案应用于晚期胃癌患者能有效提高患者缓解率,降低血MMP-9、NLR和PLR水平,改善生存预后,且安全性良好。

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胡广军(1984-),男,主任医师,主要从事胃肠道肿瘤方面的临床工作和研究

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胡广军 MP: 15230776881 E-mail:
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胡广军(1984-),男,主任医师,主要从事胃肠道肿瘤方面的临床工作和研究

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胡广军(1984-),男,主任医师,主要从事胃肠道肿瘤方面的临床工作和研究

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信迪利单抗联合化疗在晚期胃癌患者中的临床研究
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胡广军 a , 尹洪岩 b , 夏海水 c
中国临床药理学杂志 | 临床与基础桥接研究 2025,41(19): 2711-2716
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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (19) : 2711 -2716
信迪利单抗联合化疗在晚期胃癌患者中的临床研究
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胡广军(1984-),男,主任医师,主要从事胃肠道肿瘤方面的临床工作和研究

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胡广军(1984-),男,主任医师,主要从事胃肠道肿瘤方面的临床工作和研究

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胡广军a , 尹洪岩b, 夏海水c
作者信息
  • a.沧州市人民医院 胃肠外科,河北 沧州 061000
  • b.沧州市人民医院 消化内科,河北 沧州 061000
  • c.沧州市人民医院 肿瘤内科,河北 沧州 061000
通讯作者:
胡广军 MP: 15230776881 E-mail:
作者简介:

胡广军(1984-),男,主任医师,主要从事胃肠道肿瘤方面的临床工作和研究

Clinical study of sintilimab combined with chemotherapy in patients with advanced gastric cancer
Guang-jun HUa , Hong-yan YINb, Hai-shui XIAc
Affiliations
  • a.Cangzhou People’s Hospital Gastroenterology Surgery, Cangzhou 061000, Hebei Province, China
  • b.Cangzhou People’s Hospital Department of Gastroenterology, Cangzhou 061000, Hebei Province, China
  • c.Cangzhou People’s Hospital Department of Oncology, Cangzhou 061000, Hebei Province, China
出版时间: 2025-10-17 doi: 10.13699/j.cnki.1001-6821.2025.19.003
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目的

观察信迪利单抗注射液联合化疗对晚期胃癌患者的临床疗效和安全性。

方法

回顾性分析本院胃肠肿瘤中心收治的晚期胃癌患者,按治疗方案分为试验组与对照组,对照组给予XELOX化疗方案(130 mg·m-2奥沙利铂注射液,静脉滴注,每周期第1天给药;1 000 mg·m-2卡培他滨片,早晚口服,每周期第1~14天持续用药,21天为1周期),试验组在对照组基础上给予信迪利单抗注射液200 mg,静脉滴注,每周期第1天给药,21天为1周期,均治疗不超过8个周期,若患者疾病控制后给予维持方案(对照组给予单药治疗,1 000 mg·m-2卡培他滨片早晚口服,连续服用14天,停用7天,21天为1周期;试验组在对照组基础上,给予信迪利单抗注射液200 mg,静脉滴注,每周期第1天给药,21天为1周期)治疗,随访至患者死亡。比较2组患者的缓解率、包括基质金属蛋白酶9(MMP-9)、中性粒细胞与淋巴细胞比值(NLR)血小板与淋巴细胞比值(PLR)在内的血标志物及生存预后,并进行安全性评价。

结果

共纳入晚期胃癌患者86例,根据治疗方案的不同将其分为试验组和对照组,各43例,剔除在治疗过程中因个人原因自行更改药物剂量或更换治疗方法者后,最终对照组共纳入38例,试验组共纳入42例。治疗后,试验组和对照组的MMP-9水平分别为(230.74±54.37)和(311.95±69.76)μg·L-1,NLR分别为1.44±0.37和1.82±0.47,PLR分别为134.42±17.55和162.46±17.17,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(P<0.05)。试验组和对照组患者的客观缓解率分别为54.76%(23例/42例)和31.58%(12例/38例);疾病控制率分别为96.83%(40例/42例)和78.95%(30例/38例),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(P<0.05)。试验组和对照组的中位无进展生存期[95%置信区间(CI)]分别为19.00(16.89~21.11)和12.00(12.74~17.26)个月,中位总生存期(95% CI)分别为25.00(23.78~26.22)和20.00(16.98~23.02)个月,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(P<0.05)。试验组和对照组的药物不良反应中骨髓抑制发生率分别为45.24%(19例/42例)和60.53%(23例/38例),胃肠反应发生率分别为35.71%(15例/42例)和39.47%(15例/38例),肝功能损害发生率分别为26.19%(11例/42例)和21.05%(8例/38例),手足综合征发生率分别为21.43%(9例/42例)和15.79%(6例/38例),神经毒性发生率分别为40.48%(17例/42例)和52.63%(20例/38例),甲状腺功能障碍发生率分别为7.14%(3例/42例)和0.00%(0例/38例),在统计学上差异均无统计学意义(均P>0.05)。

结论

信迪利单抗注射液联合XELOX化疗方案应用于晚期胃癌患者能有效提高患者缓解率,降低血MMP-9、NLR和PLR水平,改善生存预后,且安全性良好。

信迪利单抗注射液  /  胃癌  /  晚期  /  化疗  /  缓解率  /  生存预后
Objective

To observe the clinical efficacy and safety of combination of sintilimab injection and chemotherapy on patients with advanced gastric cancer.

Methods

Patients with advanced gastric cancer in gastrointestinal tumor center of the hospital were retrospectively analyzed and divided into control group and treatment group. Control group was given XELOX chemotherapy regimen (intravenous drip of 130 mg·m-2 oxaliplatin injection on the 1st day of each cycle; oral administration of 1 000 mg·m-2 capecitabine tablets in the morning and evening, continuous medication from the 1st day to the 14th day of each cycle, 21 days as a cycle). On the basis of control group, treatment group was given 200 mg of sintilimab injection by intravenous drip on the 1st day of each cycle, and were treated no more than 8 cycles (21 days as a cycle), and received maintenance regimen (control group was given single drug treatment, 1 000 mg·m-2 capecitabine tablets orally in the morning and evening, for 14 consecutive days and 7 days of discontinuation, 21 days as a cycle; on the basis of control group, treatment group was given 200 mg of sintilimab injection, intravenous drip, on the first day of each cycle, 21 days as a cycle) after disease control. The patients were followed up until death. The remission rate, blood markers including matrix metalloproteinase-9 (MMP-9), neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) and survival prognosis were compared between the two groups, and the safety was evaluated.

Results

A total of 86 patients with advanced gastric cancer were selected from the hospital information system. According to the different treatment regimens, they were classified into control group and treatment group, with 43 cases in each group. After excluding those who changed the drug dose or changed the treatment method due to personal reasons during treatment process, 38 cases were included in control group and 42 cases were included in treatment group. After treatment, the levels of MMP-9 in treatment group and control group were (230.74±54.37) and (311.95±69.76) μg·L-1, the NLR were 1.44±0.37 and 1.82±0.47, the PLR were 134.42±17.55 and 162.46±17.17, respectively, and there were statistical significantly differences in the above indexes between treatment group and control group (all P<0.05). The objective remission rates in treatment group and control group were 54.76% (23 cases/42 cases) and 31.58% (12 cases /38 cases), and the disease control rates were 96.83% (40 cases/42 cases) and 78.95% (30 cases/38 cases), respectively, the above indicators in treatment group were statistically significantly different from those in control group (all P<0.05). The median progression-free survival [95% confidence interval (CI)] values in treatment group and control group were 19.00 (95%CI: 16.89-21.11) and 12.00 (95%CI: 12.74-17.26) months, and the median overall survival (95%CI) values were 25.00 (95%CI: 23.78-26.22) and 20.00 (95%CI: 16.98-23.02) months, respectively, the above indicators revealed statistical significantly differences between treatment group and control group (all P<0.05). The incidence rates of myelosuppression in treatment group and control group were 45.24% (19 cases/42 cases) and 60.53% (23 cases/38 cases), and the incidence rates of gastrointestinal reaction were 35.71% (15 cases/42 cases) and 39.47% (15 cases/38 cases), and incidence rates of liver function injury were 26.19% (11 cases/42 cases) and 21.05% (8 cases/38 cases), and the incidence rates of hand-foot syndrome were 21.43% (9 cases/42 cases) and 15.79% (6 cases/38 cases), and the incidence rates of neurotoxicity were 40.48% (17 cases/42 cases) and 52.63% (20 cases/38 cases), and the incidence rates of thyroid dysfunction were 7.14% (3 cases/42 cases) and 0.00% (0 cases/38 cases), respectively, without statistical significantly differences (all P>0.05).

Conclusion

The application of sintilimab injection combined with XELOX chemotherapy regimen in patients with advanced gastric cancer can effectively enhance the remission rate, reduce the levels of serum MMP-9, NLR and PLR, and improve the survival prognosis, with good safety.

sintilimab injection  /  gastric cancer  /  advanced  /  chemotherapy  /  remission rate  /  survival prognosis
胡广军, 尹洪岩, 夏海水. 信迪利单抗联合化疗在晚期胃癌患者中的临床研究. 中国临床药理学杂志, 2025 , 41 (19) : 2711 -2716 . DOI: 10.13699/j.cnki.1001-6821.2025.19.003
Guang-jun HU, Hong-yan YIN, Hai-shui XIA. Clinical study of sintilimab combined with chemotherapy in patients with advanced gastric cancer[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (19) : 2711 -2716 . DOI: 10.13699/j.cnki.1001-6821.2025.19.003
  • 河北省2022年度医学科学研究课题计划基金资助项目(20220314)
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doi: 10.13699/j.cnki.1001-6821.2025.19.003
  • 接收时间:2025-05-12
  • 首发时间:2026-08-05
  • 出版时间:2025-10-17
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  • 收稿日期:2025-05-12
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河北省2022年度医学科学研究课题计划基金资助项目(20220314)
作者信息
    a.沧州市人民医院 胃肠外科,河北 沧州 061000
    b.沧州市人民医院 消化内科,河北 沧州 061000
    c.沧州市人民医院 肿瘤内科,河北 沧州 061000

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胡广军 MP: 15230776881 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
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
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