Clinical trial · Interventional
Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin
Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin
NCT03259581CI-TRIAL-00057235completedPhase 1ClinicalTrials.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)
The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.
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 |
|---|---|---|---|
| Bilirubinemia | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transarterial chemoembolization | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transarterial chemoembolization
- description
- Transarterial chemoembolization
- interventionNames
- Combination Product: Transarterial chemoembolization
Primary outcomes (1)
- measure
- Procedure related adverse events
- timeFrame
- 1 month
- description
- Percentage of adverse events following TACE
Secondary outcomes (5)
- measure
- Radiologic Response
- timeFrame
- 1 month
- description
- mRECIST response after TACE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * hepatocellular carcinoma (HCC) * Direct or conjugated bilirubin \< 3 mg/dl * Total bilirubin \> 3 mg/dl * Willing and able to provide informed consent * \>18 years of age Exclusion Criteria: * Currently pregnant * Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference. * Arterial anatomy which would preclude selective transarterial chemoembolization * Patients who have a INR or platelet count which are not correctable to \<1.8 and \>35,000 respectively * Patients with extrahepatic metastases * Patients with portal vein invasion
References
Publications (0)
Data not yet available
No reference posted for this study.