肝脏 ›› 2026, Vol. 31 ›› Issue (8): 1129-1132.

• 肝癌 • 上一篇    下一篇

国内肝癌合并门静脉癌栓临床注册现状

张丽丽, 王韶华, 胡建华   

  1. 100089 北京 北京中西医结合医院脾胃病科(张丽丽,王绍华);
    100069 北京 首都医科大学附属北京佑安医院中西医结合中心(胡建华)
  • 收稿日期:2025-09-20 出版日期:2026-08-31 发布日期:2026-09-28
  • 通讯作者: 王韶华,Email:Wshaohua300@163.com

Clinical registration status of liver fibrosis in China

Zhang Lili1, Wang Shaohua1, Hu Jianhua2   

  1. 1. Department of Spleen and Stomach Diseases, Beijing Hospital of Integrated Chinese and Western Medicine, Beijing 100089, China;
    2. Center of Integrated Chinese and Western Medicine, Beijing You′an Hospital, Capital Medical University, Beijing 100069, China
  • Received:2025-09-20 Online:2026-08-31 Published:2026-09-28
  • Contact: Wang Shaohua, Email: Wshaohua300@163.com

摘要: 目的 整理中国临床试验注册中心(ChiCTR)数据库中肝癌合并门静脉癌栓(PVTT)临床研究的注册现状,汇总现阶段的研究成果并分析存在的问题。方法 以“门静脉癌栓”为检索词,检索中国临床试验注册中心2005年至2025年6月30日与PVTT相关的所有临床研究。结果 共纳入51项肝癌合并PVTT的临床研究,覆盖全国15个省级行政区,临床研究样本量共计6 094例,49项有明确的经费来源,研究类型共有2种,干预性研究共42项,占比最高(82.35%),观察性研究占比 17.65%。涉及7种研究方案类型,随机平行对照试验最多,共有25项(49.02 %),6项研究明确提出为开放标签试验,其余45项均未明确提及盲法情况。结论 目前,肝癌合并PVTT相关临床试验的治疗方案较多,研究成果较集中,但存在注册数量少,地域分布不均匀,经费支持占比大,缺少创新型无创诊断试验等问题。

关键词: 门静脉癌栓, 临床研究, 临床试验注册, 现状分析

Abstract: Objective In order to provide reference for the design and implementation of clinical trials in the future, this article collates the registration status of clinical studies on liver cancer combined with portal vein tumor thrombus (PVTT) in the database of the Chinese Clinical Trial Registry (ChiCTR), summarizes the current research results and analyzes the existing problems. Methods Using “portal vein tumor thrombus” as the search term, all clinical studies related to PVTT in the ChiCTR from 2005 to June 30, 2025 were searched. Results A total of 51 clinical studies on liver cancer combined with PVTT were included, covering 15 provincial administrative regions across the country. The total sample size of the clinical studies was 6 094 cases. 49 of them had clear sources of funding. There were two types of studies, among which 42 were interventional studies, accounting for the highest proportion (82.35%), and observational studies accounted for 17.65%. Seven types of research protocols were involved. Randomized parallel controlled trials were the most numerous, with a total of 25 trials (49.02%). Six studies explicitly stated that they were open-label trials, while the remaining 45 did not explicitly mention blinding. Conclusion Currently, there are many treatment options for clinical trials related to liver cancer combined with PVTT, and the research results are relatively concentrated. However, there are problems such as a small number of registrations, uneven geographical distribution, a large proportion of financial support, and a lack of innovative non-invasive diagnostic tests.

Key words: Portal vein tumor thrombus, Clinical research, Clinical trial registration, Analysis of current situation