Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Correlation between blood-based biomarkers and early radiological response
研究概览
简要总结
The goal of this observational study is to evaluate changes in selected biomarkers and their potential connection with early radiological outcomes in adult patients with hepatocellular carcinoma (HCC) who are candidates for Transarterial Chemoembolization (TACE) treatment. The main questions it aims to answer are whether specific biomarkers change in response to TACE treatment and if there is a correlation between these changes and early radiological treatment response as measured by Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Participants will undergo standard-of-care TACE as decided by a multidisciplinary team and will provide blood samples at predefined, clinically relevant time points, specifically before the first TACE procedure and during subsequent follow-up cycles on the day of either a new TACE or a control Computed Tomography (CT) scan. Additionally, participants will undergo routine clinical and radiological assessments, including multiphase CT or Magnetic Resonance Imaging (MRI) scans four to eight weeks after the procedure to monitor treatment success, with all data being collected from medical records and standard diagnostic procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •Diagnosis of hepatocellular carcinoma (HCC) based on LI-RADS CT/MRI v2018 criteria or histopathological verification
- •Candidate for TACE as part of standard treatment (BCLC criteria)
- •Child-Pugh score ≤ 7 at the time of TACE indication
- •ECOG performance status 0 at the time of TACE indication
- •Availability of at least one follow-up multiphase CT or MRI scan 4-8 weeks after TACE
排除标准
- •Child-Pugh score ≥8 at the time of TACE indication
- •Eastern Cooperative Oncology Group (ECOG) performance status > 0 at the time of TACE indication.
- •Presence of extrahepatic dissemination and/or macrovascular invasion
- •Technically unfeasible TACE (e.g., inability to identify feeder artery)
- •Severe uncorrectable coagulopathy or cytopenia
- •Severe allergy or contraindication to iodine contrast agent or drugs used during TACE
- •Pregnancy or breastfeeding
- •Inability to provide signed informed consent
研究组 & 干预措施
HCC Patients Treated With TACE
Patients with hepatocellular carcinoma (HCC) who are candidates for transarterial chemoembolization (TACE) as part of their standard clinical care. This group includes adult patients with preserved liver function (Child-Pugh ≤ 7) and good performance status Eastern Cooperative Oncology Group (ECOG) 0.
结局指标
主要结局
Correlation between blood-based biomarkers and early radiological response
时间窗: From baseline (before first TACE) up to the follow-up assessment 4-8 weeks after the procedure.
Evaluation of changes in selected biomarkers (including AFP and PIVKA-II) and their potential association with early radiological outcomes following TACE, assessed using mRECIST criteria (Complete Response, Partial Response, Stable Disease, or Progressive Disease).
次要结局
- Radiological Response Assessment via mRECIST.(4-8 weeks after each TACE procedure.)
- Changes in Tumor Marker Levels (AFP and PIVKA-II).(Baseline (Day 0, before first TACE) and at each follow-up cycle (4-8 weeks after procedure).)
- Assessment of Liver Function Post-TACE.(From baseline up to 8 weeks after the final TACE procedure.)
- Exploratory Serum Biomarker Profiling (Proteomics, miRNA, and Oxidative Stress).(From baseline (Day 0, before first TACE) up to the first follow-up assessment (4-8 weeks post-procedure).)
研究者
Marko Stojanovic
Associate Professor, Department of Pharmacology, Clinical Pharmacology and Toxicology
University of Belgrade