Clinical trial · Observational
Validation of Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma
Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- HCC Patients Treated With TACE
- description
- 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.
Primary outcomes (1)
- measure
- Correlation between blood-based biomarkers and early radiological response
- timeFrame
- From baseline (before first TACE) up to the follow-up assessment 4-8 weeks after the procedure.
- description
- 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).
Secondary outcomes (4)
- measure
- Radiological Response Assessment via mRECIST.
- timeFrame
- 4-8 weeks after each TACE procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available