基于ClinicalTrials.gov和ChiCTR登记平台数据分析鼻咽癌临床试验注册特征
贺敬龙，男，主治医师，研究方向：药物临床研究与评价。
收稿日期: 2025-06-09
修回日期: 2025-10-11
录用日期: 2025-12-03
网络出版日期: 2025-12-17
Analysis on Clinical Trial Registration Characteristics of Nasopharyngeal Carcinoma Based on Data of ClinicalTrials.gov and ChiCTR
Received date: 2025-06-09
Revised date: 2025-10-11
Accepted date: 2025-12-03
Online published: 2025-12-17
关键词： ClinicalTrials.gov; ChiCTR; 鼻咽癌; 临床试验; 注册特征
贺敬龙
,
韩京宏
,
万江帆
,
周一君
,
谢磊
,
成斌
.
基于ClinicalTrials.gov和ChiCTR登记平台数据分析鼻咽癌临床试验注册特征
Objective： To investigate the development situation and registration characteristics of nasopharyngeal carcinoma clinical trial at home and abroad.Methods： The nasopharyngeal carcinoma clinical trials registered on ClinicalTrials.gov and ChiCTR up to March 20， 2025 were retrieved. The quantity changes， basic characteristics， and methodological design of these trials were statistically analyzed.Results： A total of 1116 nasopharyngeal carcinoma clinical trials from ClinicalTrials.gov and 360 nasopharyngeal carcinoma clinical trials from ChiCTR were retrieved out. Most nasopharyngeal carcinoma clinical trials were conducted in China， especially in Guangdong province. The disease staging was mainly characterized by local advanced stage， recurrent and metastasis disease. The trial types were mainly interventional studies， with the primary purpose of disease treatment. Most clinical trials were in the early exploratory stage， and the vast majority of trials had a sample size of less than 200 cases. The most common trial designs were parallel design and single-arm design. Most trials adopted non-randomized and non-blinded designs. The main intervention measures included chemotherapy and radiotherapy. The main therapeutic targets included PD-1/PD-L1， VEGF， EGFR and cytotoxic chemotherapy drugs， etc. The common primary endpoints were survival-related endpoints.Conclusion： The number of clinical trials for nasopharyngeal carcinoma in China is currently in a leading position. It is suggested that Chinese researchers fully leverage advantage of clinical resources， improve clinical trial designs， strengthen regional research collaboration， and lead global nasopharyngeal carcinoma clinical research to a new level.
［1］ 王颢钧，肖倍倍，马骏，等.EB病毒与鼻咽癌研究进展［J］.中国科学：生命科学，2024，54（12）：2330-2343.
［2］ King AD. MR imaging of nasopharyngeal carcinoma［J］.Magn Reson Imaging Clin N Am， 2022，30（1）：19-33.
［3］ Sung H， Ferlay J， Siegel RL， et al. Global cancer statistics 2020： GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries［J］.CA Cancer J Clin， 2021，71（3）：209-249.
［4］ 陈明远.鼻咽癌诊疗规范手册［M］.北京：人民卫生出版社，2022：1021⁃1025.
［5］ Chen YP， Ismaila N， Chua MLK， et al. Chemotherapy in combination with radiotherapy for definitive-intent treatment of stage Ⅱ-IVA nasopharyngeal carcinoma： CSCO and ASCO guideline［J］， J Clin Oncol， 2021，39（7）：840-859.
［6］ Lv X， Cao X， Xia WX， et al. Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage Ⅲ-IVB nasopharyngeal carcinoma： an open-label， non-inferiority， randomised， controlled， phase 3 trial［J］.Lancet Oncol， 2021，22（5）：716-726.
［7］ Borysowski J， Górski A. ClinicalTrials.gov as a source of information about expanded access programs： cohort study［J］.J Med Internet Res， 2021，23（10）：e26890.
［8］ Liu X， Li Y， Yu X， et al. Assessment of registration quality of trials sponsored by China［J］.J Evid Based Med， 2009，2（1）：8-18.
［9］ Hong S， Zhang Y， Yu G， et al. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin as first-line therapy for recurrent or metastatic nasopharyngeal carcinoma： final overall survival analysis of GEM20110714 phase Ⅲ study［J］.J Clin Oncol， 2021，39（29）：3273-3282.
［10］ Yang Y， Pan J， Wang H， et al. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer： a multicenter phase 3 trial （RATIONALE-309） ［J］.Cancer Cell， 2023，41（6）：1061-1072.
［11］ 汪德辉，王中亮.鼻咽癌放疗后并发症研究进展［J］.中国医学文摘（耳鼻咽喉科学），2024，39（1）：180-184.
［12］ Wong KCW， Hui EP， Lo KW， et al. Nasopharyngeal carcinoma： an evolving paradigm［J］.Nat Rev Clin Oncol， 2021，18（11）：679-695.
［13］ 中国政府网.国务院关于改革药品医疗器械审评审批制度的意见［EB/OL］.（2015-08-09）［2025-03-24］.https：//www.gov.cn/gongbao/content/2015/content_2924002.htm.
［14］ 潘锋.我国卫生健康科技创新能力显著提升［J］.中国医药导报，2022，19（28）：1-6.
［15］ Jen CW， Tsai YC， Wu JS， et al. Prognostic classification for patients with nasopharyngeal carcinoma based on American Joint Committee on cancer staging system T and N categories［J］.Ther Radiol Oncol， 2020，4（2）：1-11.
［16］ 徐瑞华，李进，马军，等.中国临床肿瘤学会（CSCO）常见恶性肿瘤诊疗指南2024（下册）［M］.北京：人民卫生出版社，2024：1-44.
［17］ 谢磊，贺敬龙，徐阳美，等.基于CiteSpace的中药新药临床研究现状及前沿热点变化趋势分析［J］.中国医药导报，2024，21（27）：31-38.
［18］ 国家药品监督管理局药品审评中心.中药新药治疗恶性肿瘤临床研究指导原则［EB/OL］.（2015-11-03）［2025-03-24］.https：//www.cde.org.cn/zdyz/domesticinfopage？zdyzIdCODE=8ccaa89fa18ad332b5d7dbb09c75d5de.
［19］ Zwierzyna M， Davies M， Hingorani AD， et al. Clinical trial design and dissemination： comprehensive analysis of clinicaltrials.gov and PubMed data since 2005［J］.BMJ， 2018，6（361）：k2130.
［20］ 国家药品监督管理局药品审评中心.抗肿瘤药物临床试验终点技术指导原则［EB/OL］.（2012-05-15）［2025-03-24］.https：//www.cde.org.cn/zdyz/domesticinfopage？zdyzIdCODE=24d174aa6995cf17e7aa12d6aa0317aa./
| 〈 |
|
〉 |
