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临床试验/NCT06177496
NCT06177496尚未招募不适用

Influence of Sarcopenia on Mortality and Disease Progression in Hepatocellular Carcinoma Treated With Ablation, Embolization and Sorafenib

Sohag University0 个研究点目标入组 600 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
主要终点
overall survival

研究概览

简要总结

Liver cancer poses a major threat to the global cancer burden, and the number of deaths is estimated to be more than one million annually by 2030. Locoregional therapies such as transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and radiation are associated with improved survival and quality of life for patients with unresectable HCC [Couri and Pillai, 2019]. However, curative therapies or locoregional therapies are not applicable to approximately 50% of HCC cases who are diagnosed at an advanced stage and have progression with transarterial therapies [Park et al., 2015]. For these patients, sorafenib, lenvatinib, and atezolizumab combined with bevacizumab have been approved as the first-line systemic therapy [Fan et al., 2022].

Sarcopenia is a progressive and generalized skeletal muscle disease characterized by accelerated loss of muscle mass and function [Cruz-Jentoft and Sayer, 2019]. It has been associated with higher mortality among the general population and patients with cancer. This study aims to assess the possible role of sarcopenia in predicting the outcome of HCC patients following a variety of treatments including local ablation, TACE and sorafenib.

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

  • Clinical diagnosis of hepatocellular carcinoma.
  • Treatment-naive patients who underwent local ablation, TACE or sorafenib as a primary treatment .

排除标准

  • Use of other another HCC treatment modality e.g., resection.
  • Use of combined treatments e.g., simultaneous use of embolic therapy with ablation.
  • Patients with recurrent HCC.
  • Patients with secondaries from extra-hepatic primary tumors.
  • Incomplete data at the diagnosis, treatment or follow up time-points.
  • Loss of patients follow up.

研究组 & 干预措施

Group A

HCC patients underwent local ablation

干预措施: local ablation (Procedure)

Group B

HCC patients underwent TACE

干预措施: TACE (Procedure)

Group C

HCC patients received sorafenib

干预措施: Sorafenib (Drug)

结局指标

主要结局

overall survival

时间窗: for at least 1 year from the treatment

time from treatment till death or last contact

次要结局

  • Progression-free survival(for at least 1 year from the treatment)
  • Recurrence-free survival(for at least 1 year from the treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Abdelwahab Mohamed

Lecturer of Tropical Medicine and Gastroenterology

Sohag University

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