Article(id=1291707219289072611, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.23.003, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1747670400000, receivedDateStr=2025-05-20, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896599838, onlineDateStr=2026-08-05, pubDate=1765900800000, pubDateStr=2025-12-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896599838, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896599838, creator=13701087609, updateTime=1785896599838, updator=13701087609, issue=Issue{id=1291707045514858818, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='23', pageStart='3301', pageEnd='3450', issueExtLink='null', onlineDate='null', pubDate='1765900800000', pubDateStr='2025-12-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896558407, creator='13701087609', updateTime=1785896663780, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707487678390577, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707487682584882, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3315, endPage=3320, ext={EN=ArticleExt(id=1291707221172315108, articleId=1291707219289072611, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of trifluridine-tipiracil hydrochloride combination therapyin patients with advanced colorectal 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 trifluridine-tipiracil hydrochloride tablets combined with tislelizumab injection and fruquintinib capsules in advanced colorectal cancer patients after progression in second-line treatment.
Methods Advanced colorectal cancer patients who had progression after second-line treatment were divided into the control group and the treatment group according to the treatment methods. The control group received tislelizumab injection 200 mg combined with fruquintinib capsules 5 mg, and the treatment group received 25 mg·m2 trifluridine-tipiracil hydrochloride tablets combined with tislelizumab injection and fruquintinib capsules. A 21-day period was considered as one cycle, and both groups were treated continuously for 3 cycles. Clinical efficacy, tumor marker levels, angiogenesis factor levels, safety evaluation and survival were compared between the two groups.
Results This study enrolled 86 patients in total. The control group consisted of 45 patients, while the treatment group had 41 patients. After treatment, the disease control rates of the control group and the treatment group were 48.89% (22 cases/45 cases) and 73.17% (30 cases/41 cases), respectively; the levels of carbohydrate antigen 125 were (51.97±6.49) and (48.17±4.55) U·mL-1, respectively; the levels of cytokeratin 19 fragment antigen 21-1 were (24.41±4.54) and (21.53±3.56) μg·L-1, respectively; the levels of carcinoembryonic antigen were (30.84±6.42) and (27.76±4.44) ng·mL-1, respectively; the levels of vascular endothelial growth factor (VEGF) were (97.82±16.74) and (90.29±16.74) pg·mL-1, respectively; the levels of angiopoietin (Ang)-1 were (11 829.14±1 367.27) and (12 612.20±1 889.47) pg·mL-1, respectively; the levels of Ang-2 were (486.90±113.66) and (430.59±76.93) pg·mL-1, respectively; the levels of interleukin (IL)-8 were (10.54±2.39) and (9.05±1.85) pg·mL-1, respectively; and the median progression free survival periods were 11 and 16 months, respectively. The above indicators of the treatment group were statistically significant different compared with the control group (all P<0.05). The main adverse drug reactions in the treatment group and the control group were nausea and vomiting, leukopenia, anemia, thrombocytopenia, hematochezia, elevated alanine aminotransferase, hand-foot syndrome, hypothyroidism, oral mucositis, hypertension and proteinuria. There was no statistically significant difference in the incidence of adverse drug reactions between the treatment group and the control group (P>0.05).
Conclusion Trifluridine-tipiracil hydrochloride tablets combined with tislelizumab injection and fruquintinib capsules can significantly improve the clinical efficacy in patients with advanced colorectal cancer who progressed after second-line treatment, prolong progression-free survival, reduce angiogenesis factor levels, and have a certain degree of safety.
, authors=Li HAN, Tao YU, Ming YANG, Lai-li CHU, authorsList=Li HAN, Tao YU, Ming YANG, Lai-li CHU, authorCompany=null, correspAuthors=Tao YU, 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=1291707221482693605, articleId=1291707219289072611, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=曲氟尿苷替匹嘧啶治疗晚期结直肠癌患者的临床研究, 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 观察曲氟尿苷替匹嘧啶片与替雷利珠单抗注射液、呋喹替尼胶囊联合用于二线治疗后病情进展的晚期结直肠癌患者中的临床疗效和安全性。
方法 将二线治疗进展后的晚期结直肠癌患者，根据治疗方法分为对照组与试验组。对照组患者接受替雷利珠单抗注射液200 mg联合呋喹替尼胶囊5 mg治疗，试验组接受25 mg·m-2曲氟尿苷替匹嘧啶片联合替雷利珠单抗注射液、呋喹替尼胶囊治疗，以21天为一个周期，2组均连续治疗3个周期。比较2组临床疗效、肿瘤标志物水平、血管生成因子水平、安全性评价、生存情况。
结果 本研究共入组患者86例，对照组45例，试验组41例。治疗后，对照组和试验组的疾病控制率分别为48.89%（22例/45例）和73.17%（30例/41例），糖类抗原125分别为（51.97±6.49）和（48.17±4.55）U·mL-1，细胞角质蛋白19片段抗原21-1水平分别为（24.41±4.54）和（21.53±3.56）μg·L-1，癌胚抗原分别为（30.84±6.42）和（27.76±4.44）ng·mL-1，血管内皮生长因子（VEGF）分别为（97.82±16.74）和（90.29±16.74）pg·mL-1，血管生成素（Ang）-1分别为（11 829.14±1 367.27）和（12 612.20±1 889.47）pg·mL-1，Ang-2分别为（486.90±113.66）和（430.59±76.93）pg·mL-1，白细胞介素（IL）-8分别为（10.54±2.39）和（9.05±1.85）pg·mL-1，中位无进展生存期分别为11个月和16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（均P<0.05）。试验组和对照组的主要药物不良反应有恶心呕吐、白细胞减少、贫血、血小板减少、血便、谷丙转氨酶升高、手足综合征、甲状腺功能减退、口腔黏膜炎症、高血压、蛋白尿。试验组和对照组的各药物不良反应发生率比较，在统计学上差异无统计学意义（P>0.05）。
结论 曲氟尿苷替匹嘧啶片联合替雷利珠单抗注射液、呋喹替尼胶囊可以显著提高二线治疗进展后晚期结直肠癌患者的临床疗效，且能延长无进展生存期，降低血管生成因子水平，有一定的安全性。
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韩力（1990-），男，主治医师，主要从事消化系统肿瘤方面的临床工作和研究
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