Clinical trial · Interventional
Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma
Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment
Summary
Brief summary (as posted)
The hope to treat more patients with hepatocellular carcinoma successfully is however tempered by the shortage of donors leading to an increasing waiting time for liver transplantation (LT). Intention-to-treat analysis have showed that the reported excellent long-term outcome is curtailed and significantly hampered by the growing incidence of patients who must be removed from the waiting list because of tumor progression. A way to face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most common modality used. While there are many studies concerning TACE in this setting, none are controlled studies and thus there is no firm evidence concerning its efficacy in reducing drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial complications…) while waiting for LT. Most of the available data have been based upon analysis of patients who received a transplant and have not included patients who were eligible for LT but died, or showed progression, before it could be performed. Therefore, studies conducted on an intention-to-treat basis are needed to clarify the benefit and the risks of TACE prior to LT in patients with 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 | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-arterial administration of DC BeadsR | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intra-arterial administration of DC BeadsR
- description
- Intra-arterial administration of DC BeadsR, (1 vial of 100-300 µm) as selectively as possible loaded with doxorubicin (50 mg per procedure) and mixed with an equal volume of contrast medium. The first injection will be performed within 21 days following enlisting and repeated 1-2 times until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response
- interventionNames
- Other: Intra-arterial administration of DC BeadsR
- type
- NO_INTERVENTION
- label
- Control
- description
- Usual care
Primary outcomes (1)
- measure
- Survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients \>18 years * With well compensated cirrhosis and hepatocellular carcinoma meeting UCSF criteria * Without general contraindication to LT * Written informed consent. Exclusion Criteria: * Patients that already had TACE * Or other local treatment for HCC * Or neoadjuvant systemic chemotherapy * Or planned living donor * Or non arterialized lesion(s) * Or Contraindication to DC-BeadsR * Or allergy to contrast agents * Or contraindication to Doxorubicin.
References
Publications (0)
Data not yet available