Clinical trial · Interventional
Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique.
NCT03727633CI-TRIAL-00106832LIDA-BIIterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollement rythm low, funding body decision.
Summary
Brief summary (as posted)
The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.
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 and Lipiodol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol
- interventionNames
- Drug: Idarubicin and Lipiodol
Primary outcomes (1)
- measure
- Percentage of participants presenting a disease control at 4 months
- timeFrame
- 4 months
- description
- The primary outcome is to evaluate the disease control rate (partial, complete or stable response) 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.
Secondary outcomes (5)
- measure
- Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven HCC or according to EASL criteria * Child-Pugh A or B7 * Disease that is not suitable for resection, ablation or radiofrequency * Performance Status ECOG 0 or 1 * BCLC A/B or C if Performance Status ECOG = 1 * Measurable lesions according to mRECIST criteria * No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation * Age superior or equal to 18 years * Platelets \> 50,000/mm3, Polynuclear neutrophils \> 1000/mm3, Creatininemia \< 150umol/L, Bilirubinemia \< 5 mg/dL * Absence of heart failure (Ultrasound LVEF \> 50%) * Women of child-bearing age using an adequate method of contraception throughout treatment * Men using an adequate method of contraception throughout the treatment and at least 3 months after the end of treatment * Written informed consent * National health insurance cover Exclusion Criteria: * Advanced tumor disease (extrahepatic except pulmonary micronodules \<7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.) * Large HCC with liver invasion \>50% * History of other cancer than HCC and excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ treated with adequate and curative purpose * Advanced liver disease (Child B8, B9 or C) * Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure) * Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine). * Contra-indication to idarubicin (Hypersensibility to active substance or excipients, cardiopathy with myocardial insufficiency of less than 6 months, serious arrhythmias, serious renal or liver failure, yellow fever vaccine or any other live attenuated vaccine, persistente myelosuppression, previous treatments with idarubicin and/or other anthracyclines or anthracenediones at maximum cumulative doses, stomatitis) * Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding) * Concomitant disease or uncontrolled severe clinical situation * Uncontrolled severe infection * Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments * Pregnancy (Beta HCG positive) or breastfeeding * Patient who for psychological, social, family or geographical reasons cannot be followed regularly * Vulnerable person * Concomitant participation of the patient in another research involving the human person
References
Publications (0)
Data not yet available
No reference posted for this study.