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临床试验/NCT05703750
NCT05703750招募中不适用

Impact of Clinical Evident Portal Hypertension on Hepatocellular Carcinoma With Transarterial Chemoembolization (CHANCE-CHESS 2301): A Multicenter Retrospective Study

Zhongda Hospital2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2023年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
228
试验地点
2
主要终点
Overall Survival(OS)

研究概览

简要总结

The purpose of this study is to discuss the prognostic value of CEPH among HCC patients underwent TACE treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.

详细描述

Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the second leading cause of cancer-related deaths globally. Transarterial chemoembolization (TACE) is recommended as standard therapy for intermediate-stage HCC according to the current guidelines and is also the most widely used in advanced HCC in real-world practice. Clinically relevant portal hypertension increases the risk of hepatic decompensation, which impairs survival in patients with HCC. The purpose of this study is to discuss the prognostic value of CEPH among HCC patients who underwent TACE treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
  • Received at least 1 TACE treatment;

排除标准

  • Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
  • ECOG Performance Score > 2;
  • History of spleen resection;
  • Loss to follow-up.

结局指标

主要结局

Overall Survival(OS)

时间窗: up to approximately 2 years

The OS is defined as the time from the initiation of any treatment to death due to any cause.

次要结局

  • Objective response rate(ORR) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)(up to approximately 2 years)
  • Progression free survival(PFS) per mRECIST(up to approximately 2 years)

研究者

发起方
Zhongda Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao-jun Teng

President

Zhongda Hospital

研究点 (2)

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