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临床试验/NCT05704192
NCT05704192招募中不适用

Non-invasive CT-based Hepatic Venous Pressure Gradient Assessment for Predicting the Prognosis of Hepatocellular Carcinoma With Transarterial Chemoembolization (CHANCE-CHESS 2302): A Multicenter Retrospective Study

Zhongda Hospital2 个研究点 分布在 1 个国家目标入组 373 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
373
试验地点
2
主要终点
Overall Survival(OS)

研究概览

简要总结

This study aims to evaluate the impact of non-invasive CT-based Hepatic Venous Pressure Gradient (HVPG) assessment on prognosis of hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE).

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. Portal hypertension increases the risk of hepatic decompensation, which impairs survival in patients with HCC. Clinically significant portal hypertension is defined as >10 mmHg increase in the hepatic vein pressure gradient (HVPG), and the current gold standard for its assessment is direct measurement, through a transjugular approach. However, due to its invasive character and high effort, HVPG measurement is not a standard tool in the initial diagnostic evaluation of patients with HCC. This study aims to evaluate the impact of non-invasive CT-based Hepatic Venous Pressure Gradient (HVPG) assessment on prognosis of hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE).

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;
  • Contrast-enhanced computed tomography (CECT) examination within 1 month before the first TACE treatment;

排除标准

  • Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
  • Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) > 2;
  • History of liver or spleen resection;
  • Loss to follow-up;
  • CECT image data was incomplete, unclear, or artifact occurred.

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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