Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 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 prospective observational study is to validate the clinical utility of specific blood-based biomarkers for predicting and monitoring treatment response in patients with hepatocellular carcinoma (HCC) undergoing Transarterial Chemoembolization (TACE).
The study aims to determine if longitudinal changes in these biomarkers can reliably correlate with early radiological treatment response, as measured by Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Participants will receive standard-of-care TACE treatment and will provide blood samples at baseline and during subsequent clinical follow-up cycles. Biomarker levels will be compared against routine multiphase computed tomography (CT) or Magnetic Resonance Imaging (MRI) scans performed four to eight weeks post-procedure to establish their accuracy as predictive tools for clinical success.
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