Article(id=1292126363142607481, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.04.006, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1758470400000, receivedDateStr=2025-09-22, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996531520, onlineDateStr=2026-08-06, pubDate=1772208000000, pubDateStr=2026-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996531520, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996531520, creator=13701087609, updateTime=1785996531520, updator=13701087609, issue=Issue{id=1292126355785802497, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1772208000000', pubDateStr='2026-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996529766, creator='13701087609', updateTime=1786014519902, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201811952292026, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201811952292027, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=486, endPage=491, ext={EN=ArticleExt(id=1292126363398460026, articleId=1292126363142607481, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of sintilimab combined with SOX regimen as neoadjuvant therapy for patients with locally advanced gastric cancer, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To investigate the efficacy and safety of sintilimab injection combined with S-1 capsules/oxaliplatin injection (SOX) regimen as neoadjuvant therapy for patients with locally advanced gastric cancer (LAGC).
Methods LAGC patients were divided into control group and treatment group based on treatment methods. The control group received neoadjuvant chemotherapy with the SOX regimen, with intravenous infusion of oxaliplatin injection 135 mg·m-2 on the first day of each cycle, and S-1 capsules were administered orally according to the patient’s body surface area (40 mg each time for <1.25 m2, 50 mg each time for 1.25-1.50 m2, and 60 mg each time for >1.50 m2), twice a day, for 1-14 days, with every 3 weeks as one cycle. The treatment group received sintilimab injection 200 mg intravenously on the first day of each cycle (every 3 weeks as one cycle) in addition to the control group’s treatment. After both groups completed 4 cycles of treatment, radical gastrectomy+D2 lymph node dissection was performed. The clinical efficacy, tumor marker levels, safety, and survival status of the two groups were compared.
Results The control group included 48 cases, and the treatment group included 52 cases. The effective rates of the control group and the treatment group were 52.08% (25 cases/48 cases) and 73.08% (38 cases/52 cases), respectively, After treatment, the levels of carcinoembryonic antigen (CEA) in the control group and the treatment group were (21.08±3.30) and (19.52±2.90) ng·mL-1, respectively; the levels of carbohydrate antigen (CA) 19-9 were (43.89±5.11) and (41.57±4.73) U·mL-1, respectively; the levels of CA 72-4 were (24.82±3.15) and (23.18±2.79) U·mL-1, respectively; the median progression-free survival was 27 and 40 months, respectively; and the median overall survival was 33 and 46 months, respectively. The above indicators of the treatment group were all statistically significantly different from those of the control group (P<0.05, P<0.01). The incidence rates of nausea and vomiting in the control group and the treatment group were 25.00% (12 cases/48 cases) and 15.38% (8 cases/52 cases), respectively; the incidence rates of diarrhea were 14.58% (7 cases/48 cases) and 11.54% (6 cases/52 cases), respectively; the incidence rates of bone marrow suppression were 29.17% (14 cases/48 cases) and 32.69% (17cases/52 caes), respectively, with no statistically significant difference (all P>0.05).
Conclusion Sintilimab combined with SOX regimen as neoadjuvant therapy for LAGC patients can achieve good clinical efficacy, improve functional status, prolong survival, reduce tumor marker levels, and has fewer surgery-related complications and good safety.
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目的 研究信迪利单抗注射液联合替吉奥胶囊/奥沙利铂注射液（SOX）方案术前新辅助治疗局部进展期胃癌（LAGC）患者的疗效和安全性。
方法 将LAGC患者根据治疗方法分为对照组与试验组。对照组患者接受新辅助化疗方案SOX方案治疗，每周期第1天静脉滴注奥沙利铂注射液135 mg·m-2，替吉奥胶囊按照患者体表面积口服（<1.25 m2时，每次40 mg；1.25~1.50 m2时，每次50 mg；>1.50 m2时，每次60 mg），每天2次，用药1~14天，每3周为1个周期。试验组在对照组基础上于每个周期（每3周作为1个周期）的第1天予以信迪利单抗注射液200 mg静脉滴注。2组均完成4个周期的治疗后，行胃癌根治术+D2淋巴结清扫术。比较2组患者的临床疗效、肿瘤标志物水平、安全性、生存情况。
结果 对照组入组48例、试验组入组52例。对照组和试验组治疗有效率分别为52.08%（25例/48例）和73.08%（38例/52例），治疗后，对照组和试验组癌胚抗原（CEA）水平分别为（21.08±3.30）和（19.52±2.90）ng·mL-1，糖类抗原（CA）19-9水平分别为（43.89±5.11）、（41.57±4.73）U·mL-1，CA 72-4水平分别为（24.82±3.15）和（23.18±2.79）U·mL-1，中位无进展生存期分别为27和40个月，中位总生存期分别为33和46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，P<0.01）；对照组和试验组主要药物不良反应，例如恶心呕吐发生率分别为25.00%（12例/48例）和15.38%（8例/52例），腹泻发生率分别为14.58%（7例/48例）和11.54%（6例/52例），骨髓抑制发生率分别为29.17%（14例/48例）和32.69%（17例/52例），2组间比较，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SOX方案术前新辅助治疗LAGC患者能够取得较好的临床疗效，改善功能状态，延长生存情况，降低肿瘤标志物水平，且手术相关并发症较少，安全性较好。
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谢钊（1977-），男，主治医师，主要从事胃肠道肿瘤诊疗方面的工作和研究
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