Article(id=1322245766500955075, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1597248000000, acceptedDateStr=2020-08-13, onlineDate=1793177556872, onlineDateStr=2026-10-28, pubDate=1622304000000, pubDateStr=2021-05-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177556872, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177556872, creator=13701087609, updateTime=1793177556872, updator=13701087609, issue=Issue{id=1322245734427112160, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='10', pageStart='865', pageEnd='960', issueExtLink='null', onlineDate='null', pubDate='1622304000000', pubDateStr='2021-05-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177549225, creator='13701087609', updateTime=1793177686658, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322246311269740715, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322246311269740716, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=871, endPage=875, ext={EN=ArticleExt(id=1322245766916191172, articleId=1322245766500955075, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Consideration on key points of clinical trials for advanced renal cell carcinoma in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Renal cell carcinoma is a common type of urinary solid tumor. Targeted drugs have greatly improved the survival of patients with advanced renal cell carcinoma, but most patients will eventually develop drug resistance. Therefore, it is necessary to explore new treatment methods. In recent years, the application of immune checkpoint inhibitors has brought new hope to patients and further extended the survival time of patients. This article describes the key points of clinical trials for advanced renal cell carcinoma in China from the perspective of drug evaluation, aiming to provide a reference for the development of therapeutic drugs for renal cell carcinoma in China.

, authors=Lin XIA, Yuan-yuan SONG, Rui-min HAO, Zhi-min YANG, authorsList=Lin XIA, Yuan-yuan SONG, Rui-min HAO, Zhi-min YANG, authorCompany=null, correspAuthors=Zhi-min YANG, 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=1322245767390147525, articleId=1322245766500955075, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=我国晚期肾细胞癌临床试验关注要点的考虑, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

肾细胞癌是泌尿系统常见的恶性肿瘤之一,分子靶向药物显著提高了晚期肾细胞癌患者的生存时间,但整体治疗效果仍不理想,即使初期治疗有效的患者也终将产生耐药而进展,因此需要不断探索研究新的诊疗手段。近年来,免疫检查点抑制剂的应用给患者带来了新的希望,进一步延长了患者的生存期。本文从审评的角度阐述我国晚期肾细胞癌临床试验关注要点,以期为我国晚期肾细胞癌的新药研发提供参考。

, authors=夏琳, 宋媛媛, 郝瑞敏, 杨志敏, authorsList=夏琳, 宋媛媛, 郝瑞敏, 杨志敏, authorCompany=null, correspAuthors=杨志敏, authorNote=

夏琳,女,主治医师,审评员,主要从事药品临床审评工作。联系电话:(010)85242691,E-mail:。

, correspAuthorsNote=
杨志敏,女,主任药师,高级审评员,主要从事药品临床审评工作。联系电话:(010)85242698,E-mail:。
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夏琳,女,主治医师,审评员,主要从事药品临床审评工作。联系电话:(010)85242691,E-mail:。

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夏琳,女,主治医师,审评员,主要从事药品临床审评工作。联系电话:(010)85242691,E-mail:。

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我国晚期肾细胞癌临床试验关注要点的考虑
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夏琳 , 宋媛媛 , 郝瑞敏 , 杨志敏
中国新药杂志 | 新药注册与审评技术 2021,30(10): 871-875
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中国新药杂志 |新药注册与审评技术 2021 , 30 (10) : 871 -875
我国晚期肾细胞癌临床试验关注要点的考虑
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夏琳,女,主治医师,审评员,主要从事药品临床审评工作。联系电话:(010)85242691,E-mail:。

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夏琳 , 宋媛媛, 郝瑞敏, 杨志敏
作者信息
  • 国家药品监督管理局药品审评中心,北京 100022
通讯作者:
杨志敏,女,主任药师,高级审评员,主要从事药品临床审评工作。联系电话:(010)85242698,E-mail:。
作者简介:

夏琳,女,主治医师,审评员,主要从事药品临床审评工作。联系电话:(010)85242691,E-mail:。

Consideration on key points of clinical trials for advanced renal cell carcinoma in China
Lin XIA , Yuan-yuan SONG, Rui-min HAO, Zhi-min YANG
Affiliations
  • Center for Drug Evaluation, China National Medical Products Administration, Beijing 100022, China
出版时间: 2021-05-30
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肾细胞癌是泌尿系统常见的恶性肿瘤之一,分子靶向药物显著提高了晚期肾细胞癌患者的生存时间,但整体治疗效果仍不理想,即使初期治疗有效的患者也终将产生耐药而进展,因此需要不断探索研究新的诊疗手段。近年来,免疫检查点抑制剂的应用给患者带来了新的希望,进一步延长了患者的生存期。本文从审评的角度阐述我国晚期肾细胞癌临床试验关注要点,以期为我国晚期肾细胞癌的新药研发提供参考。

晚期肾细胞癌  /  靶向治疗  /  免疫检查点抑制剂  /  临床试验关注要点

Renal cell carcinoma is a common type of urinary solid tumor. Targeted drugs have greatly improved the survival of patients with advanced renal cell carcinoma, but most patients will eventually develop drug resistance. Therefore, it is necessary to explore new treatment methods. In recent years, the application of immune checkpoint inhibitors has brought new hope to patients and further extended the survival time of patients. This article describes the key points of clinical trials for advanced renal cell carcinoma in China from the perspective of drug evaluation, aiming to provide a reference for the development of therapeutic drugs for renal cell carcinoma in China.

advanced renal cell carcinoma  /  targeted therapy  /  immune checkpoint inhibitor  /  clinical trial key points
夏琳, 宋媛媛, 郝瑞敏, 杨志敏. 我国晚期肾细胞癌临床试验关注要点的考虑. 中国新药杂志, 2021 , 30 (10) : 871 -875 .
Lin XIA, Yuan-yuan SONG, Rui-min HAO, Zhi-min YANG. Consideration on key points of clinical trials for advanced renal cell carcinoma in China[J]. Chinese Journal of New Drugs, 2021 , 30 (10) : 871 -875 .

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2021年第30卷第10期
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  • 首发时间:2026-10-28
  • 出版时间:2021-05-30
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  • 录用日期:2020-08-13
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    国家药品监督管理局药品审评中心,北京 100022

通讯作者:

杨志敏,女,主任药师,高级审评员,主要从事药品临床审评工作。联系电话:(010)85242698,E-mail:。
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