Clinical trial · Interventional
Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
NCT03533920CI-TRIAL-00035088completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Conditions
Conditions (1)
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 Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UNI-DEB | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- UNI-DEB
- interventionNames
- Device: UNI-DEB
Primary outcomes (1)
- measure
- Objective Response Rate by independent evaluator
- timeFrame
- 4 weeks after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Over 19 years * Diagnosis of HCC * Unresectable asymtomatic uninodular or multinodular tumor. * Subject who maintain clinically normal hepatopetal flow without main portal vein closure * At least one measurable target lesion by CT or MRI which 10 mm or more and 100 mm or less. * ECOG Performance Status of 0 or 1. * Child-Pugh class A or B * Life expectancy of at least 6 months. Exclusion Criteria: * Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia * Hepatic resection, liver transplantation or Percutaneous local treatment * Previously received HCC related medical procedure * Previously treated with anthracyclines * Only measurable disease is within an area of the liver previously subjected to radiotherapy. * Child Pugh C * Active gastrointestinal bleeding within 6 months from screening. * Total bilirubin \> 3mg/dL * WBC \< 3,000cells/mm3 * Platelet \< 50,000mm3 * Serum creatinine \> 2mg/dL * INR\> 1.4 * ALT and AST \> 5 times UNL * Diffuse HCC defined as \>50% tumour involvement of the whole liver.
References
Publications (0)
Data not yet available
No reference posted for this study.