Article(id=1292126521540505960, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.03.005, 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=1785996569284, onlineDateStr=2026-08-06, pubDate=1771257600000, pubDateStr=2026-02-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996569284, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996569284, creator=13701087609, updateTime=1785996569284, updator=13701087609, issue=Issue{id=1292126460546929080, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='3', pageStart='301', pageEnd='450', issueExtLink='null', onlineDate='null', pubDate='1771257600000', pubDateStr='2026-02-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996554742, creator='13701087609', updateTime=1786014541627, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201903060963536, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201903060963537, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=326, endPage=332, ext={EN=ArticleExt(id=1292126521737638249, articleId=1292126521540505960, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trail of PD-1 inhibitor targeted therapy combined with mFOLFOX6 chemotherapy regimen in preoperative neoadjuvant treatment of locally advanced middle-low rectal 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 programmed death-1 (PD-1) inhibitor targeted therapy combined with the oxaliplatin+5-fluorouracil+calcium leucovorin (mFOLFOX6) chemotherapy regimen in the preoperative neoadjuvant treatment of locally advanced middle-low rectal cancer.
Methods Elderly patients with locally advanced middle-low rectal cancer were divided into control group and treatment group according to the treatment method. Patients in the control group received the conventional mFOLFOX6 chemotherapy regimen, with one cycle every 2 weeks for a total of 4 cycles. Patients in the treatment group received the conventional neoadjuvant chemotherapy with the mFOLFOX6 regimen combined with the PD-1 inhibitor camrelizumab injection (200 mg intravenously infused on day 1 of each cycle), with one cycle every 2 weeks for a total of 4 cycles. The surgical intervention was undertaken 4-6 weeks following completion of the chemotherapy regimen. The short-term efficacy evaluation of solid tumors, malignant tumor markers, anorectal dynamics and surgical efficiency were compared between the two groups and the safety was evaluction.
Results A total of 97 patients were recruited, with 54 assigned to the control group and 43 in the treatment group. After treatment, the objective response rates (ORR) were 25.93% (14 cases/54 cases) in the control group and 48.84% (21 cases/43 cases) in the treatment group; the disease control rates (DCR) were 57.41% (31 cases/54 cases) in the control group and 76.74% (33 cases/43 cases) in the treatment group, with statistically significant differences (P<0.05). After treatment, the carcinoembryonic antigen (CEA) levels in the control group and treatment group were (3.27±0.48) and (2.75±0.43) μg·L-1, respectively; the carbohydrate antigen 199 (CA199) levels were (22.19±3.17) and (19.80±2.94) KU·L-1, respectively. The above indicators demonstrated statistically significant differences between the treatment and control groups (all P<0.001). After treatment, the rectal resting pressure (RRP) levels in the control group and treatment group were (11.36±1.75) and (13.95±2.03) mmHg, respectively; the maximal tolerable rectalvolume (MTV) levels were (142.97±18.39) and (135.43±15.96) mL, respectively; the rectal compliance (RC) levels were (3.13±0.58) and (2.75±0.39) mL·mmHg-1, respectively. The above indicators demonstrated statistically significant differences between the treatment and control groups (all P<0.05). The incidence of postoperative complications was 20.37% (11 cases/54 cases) in the control group and 18.60% (8 cases/43 cases) in the treatment group, with no statistically significant difference (P>0.05).
Conclusion Preoperative targeted therapy with a PD-1 inhibitor combined with the mFOLFOX6 chemotherapy regimen can significantly improve the short-term efficacy of solid tumors, reduce tumor marker levels, optimize anorectal dynamics and quality of life in patients with locally advanced middle-low rectal cancer, with mild immunosuppression and good safety.
, authors=Long-fei QU, Kai-hua LIU, Guo-qiang SU, authorsList=Long-fei QU, Kai-hua LIU, Guo-qiang SU, authorCompany=null, correspAuthors=Guo-qiang SU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292126521993490794, articleId=1292126521540505960, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=PD-1抑制剂靶向治疗联合mFOLFOX6化疗方案在局部进展期中低位直肠癌术前新辅助治疗中的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 探究程序性死亡受体1（PD-1）抑制剂靶向治疗联合奥沙利铂+氟尿嘧啶+亚叶酸钙（mFOLFOX6）化疗方案在局部进展期中低位直肠癌术前新辅助治疗中的临床疗效和安全性。
方法 将局部进展期中低位直肠癌老年患者根据治疗方法分为对照组和试验组。对照组患者常规行mFOLFOX6化疗方案，每2周1个周期，治疗4个周期。试验组患者常规行mFOLFOX6方案同时第1天联合应用PD-1抑制剂卡瑞利珠单抗注射剂，200 mg静脉输注，每2周1个周期，治疗4个周期。化疗结束后的4~6周内行手术治疗。比较2组实体肿瘤近期疗效评价、恶性肿瘤标志物、肛肠动力学、手术效率，并进行安全性评价。
结果 共入组97例患者，其中对照组54例，试验组43例。治疗后，对照组和试验组的客观有效率（ORR）分别为25.93%（14例/54例）和48.84%（21例/43例），疾病控制率（DCR）分别为57.41%（31例/54例）和76.74%（33例/43例），2组间比较，在统计学上差异均有统计学意义（均P<0.05）。治疗后，对照组和试验组的癌胚抗原（CEA）分别为（3.27±0.48）和（2.75±0.43）μg·L-1，糖类抗原（CA）199分别为（22.19±3.17）和（19.80±2.94）KU·L-1，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（均P<0.001）。治疗后，对照组和试验组的直肠静息压（RRP）分别为（11.36±1.75）和（13.95±2.03）mmHg，直肠最大耐受容量（MTV）分别为（142.97±18.39）和（135.43±15.96）mL，直肠顺应性（RC）分别为（3.13±0.58）和（2.75±0.39）mL·mmHg-1，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（均P<0.05）。对照组和试验组的术后并发症发生率为20.37%（11例/54例）和18.60%（8例/43例），在统计学上差异无统计学意义（P>0.05）。
结论 术前使用PD-1抑制剂进行靶向治疗并结合mFOLFOX6化疗方案，有助于提高局部进展期中低位直肠癌患者实体肿瘤疗效评价，改善肿瘤标志物水平、肛肠动力学及生活质量，且对免疫功能抑制较轻、安全性良好。
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曲龙飞（1990-），男，主治医师，主要从事结直肠肿瘤外科方面的临床工作和研究
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