Clinical trial · Interventional
Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas
Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial
NCT01040559CI-TRIAL-00008838completedPhase 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 purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic 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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Idarubicin
- description
- Dose escalation: level0 = idarubicin 5mg, level1 = idarubicin 10mg, level2 = idarubicin 15mg, level3 = idarubicin 20mg, level4 = idarubicin 25mg
- interventionNames
- Drug: idarubicin
Primary outcomes (1)
- measure
- Dose-limiting toxicity assessed according NCI CTC AE v3.0
- timeFrame
- Within the first month after chemoembolization
Secondary outcomes (3)
- measure
- Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria.
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Hepatocellular carcinoma cytologically or histologically proved or diagnosed according the criteria of the American Association for the Study of Liver Diseases(AASLD 2005) * Three nodules maximum (unilobar disease without limitation in the number of nodules; 3 maximum nodules if bilobar disease \[satellite nodules \<1cm not included in the total sum\]) * Child-Pugh score A or B7 * ECOG Performance Status \< 2 * Platelet count \> 50,000/µl and absolute neutrophil count (ANC) \>1,000/µl * Serum creatinine \< 150 µmol/l * Resting ejection fraction \> 50% (echocardiography or isotopic method) * Age \> 18 years * Signed written informed consent Exclusion Criteria: * Patients eligible for surgical resection or hepatic transplantation or radiofrequency ablation * Extrahepatic metastases * Known gastrointestinal bleeding up to 30 days before study entry * Patients with anticoagulant treatment * Evidence of portal vein thrombosis * Pregnancy * Clinically serious infection * Known hypersensitivity to anthracyclines * Known hypersensitivity to contrast medium
References
Publications (2)
- DERIVEDAnota A, Boulin M, Dabakuyo-Yonli S, Hillon P, Cercueil JP, Minello A, Jouve JL, Paoletti X, Bedenne L, Guiu B, Bonnetain F. An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma. BMJ Open. 2016 Jun 24;6(6):e010696. doi: 10.1136/bmjopen-2015-010696. PMID 27342239
- DERIVEDBoulin M, Hillon P, Cercueil JP, Bonnetain F, Dabakuyo S, Minello A, Jouve JL, Lepage C, Bardou M, Wendremaire M, Guerard P, Denys A, Grandvuillemin A, Chauffert B, Bedenne L, Guiu B. Idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma: results of the IDASPHERE phase I trial. Aliment Pharmacol Ther. 2014 Jun;39(11):1301-13. doi: 10.1111/apt.12746. Epub 2014 Apr 16. PMID 24738629