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Real-world Insight Into Systemic Therapies for HCC: Single-center Study (HCC)

2026年9月8日 更新者：Mahmoud Elbendary、Mansoura University

Real-world Insight Into Systemic Therapies for Hepatocellular Carcinoma: a Comprehensive Single-center Study

Real-world data from a single-center experience evaluating patients with hepatocellular carcinoma (HCC) receiving systemic therapies

研究概览

地位

招聘中

条件

详细说明

This retrospective cohort study will be conducted at the Tropical Medicine Department of Mansoura University Hospitals, recruiting patients with advanced hepatocellular carcinoma (HCC) who will receive systemic therapy between June 2022 and November 2024. Eligible participants will include those with Child-Pugh class A liver function, ECOG performance status 0-1, and Barcelona Clinic Liver Cancer (BCLC) stage C, or stage B with diffuse, infiltrative, or extensive bilobar involvement, or progression after transarterial chemoembolization (TACE). Additional laboratory and clinical criteria will be required, such as adequate blood counts, liver and renal function, and absence of large or risky esophageal varices. Patients with Child-Pugh class B or C, early or terminal stage disease, or contraindications to systemic therapy such as active infections, autoimmune conditions, or severe comorbidities will be excluded.

Operationally, all patients will undergo comprehensive history taking, physical examination, radiological imaging (ultrasound, triphasic CT, or MRI), and laboratory testing, including liver function, renal function, virology markers, and tumor biomarkers such as alpha-fetoprotein (AFP). Follow-up assessments will be performed every three months using physical exams, imaging, and laboratory tests to monitor disease progression and treatment outcomes. Data will be systematically collected and analyzed using SPSS version 25, with qualitative variables expressed as frequencies and percentages, and quantitative data assessed for normality and described accordingly. Statistical tests such as Chi-square and correlation analyses will be applied to evaluate associations, with the ultimate aim of estimating progression-free survival and overall survival in this patient population.

研究类型

观察性的

注册 (估计的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 埃及
    • Dakahlia Governorate
      • Al Mansurah、Dakahlia Governorate、埃及、35516
        • 招聘中
        • Mansoura University Hospitals
        • 接触：
        • 首席研究员：
          • Mahmoud M El-Bendary, MD
        • 副研究员：
          • Nada Hussien, Msc
        • 副研究员：
          • Mohamed Awad
        • 副研究员：
          • Ahmed El-Eraky

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with HCC that are recruited to the tropical medicine inpatient department and outpatient clinics and are submitted to the inclusion and exclusion criteria from June 2022 to November 2024.

描述

Inclusion Criteria:

  • patient with HCC
  • Child-Pugh class A, B7
  • Performance state 0-1 (Eastern Cooperative Oncology Group (ECOG scale).
  • Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B with diffuse, infiltrative or extensive bilobar involvement or BCLC stage B with tumor progression after TACE.

Exclusion Criteria:

  • patient with other tumor than HCC
  • Child-Turcotte-Pugh score B (8,9) and C.
  • Patients eligible for treatment other than systemic therapy according to Barcelona Clinic liver cancer.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
HCC patients on systemic therapies
  1. HCC patients receiving TKI (Sorafenib and Regrofenib
  2. HCC patients receiving Atezolizumab with Bevacizumab
  3. HCC patients receiving Tremelimumab with Durvalumab 4 -HCC patients With positive PCR HCV treating by DAAs with systemic therapy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
overall survival (OS)
大体时间：1 year
time from initiation of systemic therapy to death from any cause
1 year
treatment response
大体时间：1 year

m-RESIST analysis of the patients as its categories

  • CR - Complete response Disappearance of all arterial enhancement in all target lesions
  • PR - Partial response ≥30% decrease in the sum of diameters of viable tumor
  • SD - Stable disease Neither sufficient decrease for PR nor sufficient increase for PD
  • PD - Progressive disease ≥20% increase in the sum of viable tumor diameters, with an absolute increase of ≥5 mm, or appearance of new lesions/other progression criteria
1 year
progression free survival (PFS)
大体时间：one year
time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first
one year

次要结果测量

结果测量
措施说明
大体时间
efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy
大体时间：1 year

treatment of HCV infection in patient with HCC and active HCV infection during receiving systemic therapy of HCC which will be assed by PCR done 12 w after the end of treatment ,

  • SVR: HCV RNA remains undetectable 12 weeks after completing treatment. This is the standard definition of virologic cure.
  • Or non responder as HCV RNA is still detected after 12 w of complete treatment -how it will affect liver function
1 year

其他结果措施

结果测量
措施说明
大体时间
Side effects
大体时间：1 year
adverse events related to systemic therapy of HCC
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Mansoura University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月1日

初级完成 (估计的)

2027年12月15日

研究完成 (估计的)

2027年12月15日

研究注册日期

首次提交

2026年8月27日

首先提交符合 QC 标准的

2026年9月8日

首次发布 (实际的)

2026年9月10日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MS.24.11.2985

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Will be shared after reasonable request

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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