Real-world Insight Into Systemic Therapies for Hepatocellular Carcinoma: a Comprehensive Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- overall survival (OS)
研究概览
简要总结
Real-world data from a single-center experience evaluating patients with hepatocellular carcinoma (HCC) receiving systemic therapies
详细描述
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
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HCC patients on systemic therapies
- HCC patients receiving TKI (Sorafenib and Regrofenib
- HCC patients receiving Atezolizumab with Bevacizumab
- HCC patients receiving Tremelimumab with Durvalumab 4 -HCC patients With positive PCR HCV treating by DAAs with systemic therapy
结局指标
主要结局
overall survival (OS)
时间窗: 1 year
time from initiation of systemic therapy to death from any cause
treatment response
时间窗: 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
progression free survival (PFS)
时间窗: one year
time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first
次要结局
- efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy(1 year)
研究者
Mahmoud Elbendary
Professor of Tropical Hepatogastroenterology- Tropical Medicine department
Mansoura University
