Clinical trial · Observational
LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable HCC (PARIS Registry)
LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable Hepacellular Carcinoma
NCT03053596CI-TRIAL-00042980completedClinicalTrials.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 main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment.
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 |
|---|---|---|---|
| DEB-TACE using anthracyclin loaded LifePearl™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Liver toxicity assessment based on routine CT scans
- timeFrame
- 12 months
Secondary outcomes (4)
- measure
- Liver toxicity assessment based on routine blood tests: liver enzymes, phosphatase alkaline, GGT, CBC, bilirubin, albumin. Number of participants with changes in liver function related to TACE treatment.
- timeFrame
- 12 months
- measure
- Treatment efficacy based on response rate assessed by mRECIST criteria
- timeFrame
- 3 months after final TACE
- measure
- Treatment efficacy based on response rate assessed by RECIST 1.1 criteria
- timeFrame
- 3 months after final TACE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients, more than 18 years old, with unresectable hepatocellular carcinoma eligible for treatment with anthracyclin loaded LifePearls, allocated to TACE treatment at multidisciplinary tumor board and who agree to data collection in the registry by signing informed consent form. Exclusion Criteria: * This is an observational registry and there are no exclusion criteria apart from patient refusal.
References
Publications (1)
- DERIVEDde Baere T, Guiu B, Ronot M, Chevallier P, Sergent G, Tancredi I, Tselikas L, Dioguardi Burgio M, Raynaud L, Deschamps F, Verset G. Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry. Cancers (Basel). 2020 Nov 17;12(11):3405. doi: 10.3390/cancers12113405. PMID 33212917