Clinical trial · Interventional
The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol
Hepatocellular Carcinoma Under 3 cm Treated by Percutaneous Tumor Destruction: Multicentric Phase 2 Test Evaluating the Impact of Adjuvant Chemotherapy by Intra-arterial Infusion of Idarubicin-lipiodol on the Hepatic Recurrence
NCT04178642CI-TRIAL-00062680LIDA-ADJwithdrawnPhase 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): no participants enrolled
Summary
Brief summary (as posted)
The aim of this study is to test whether the realization of 3 courses of intra-arterial chemotherapy of idarubicin-lipiodol without embolization, administered non-selectively in the hepatic artery, following the percutaneous tumour ablation of a hepatocellular carcinoma, could constitute an effective adjuvant treatment to reduce the rates of local and intrahepatic distant recurrence and thus improve the survival without hepatic progression.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Percutaneous destruction of the tumor | Procedure | — | UNRESOLVED |
| percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- (experimental group)
- description
- Evaluating the efficacy of an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin-Lipiodol (experimental group)
- interventionNames
- Drug: percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment
- type
- ACTIVE_COMPARATOR
- label
- (standard group)
- description
- The absence of adjuvant treatment (standard group).
- interventionNames
- Procedure: Percutaneous destruction of the tumor
Primary outcomes (1)
- measure
- The survival rate without hepatic recurrence at 1 year
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age above 18 and under 80 years-old * Chronic or histologically proven stage F3 or F4 hepatopathy, with liver hardness ≥ 10 kPa, or with imaging morphology suggestive of cirrhosis or portal hypertension * Child-Pugh score ≤ B7 * Patients whose biological parameters meet the following criteria: * Platelets \> 50,000 / mm3 * Neutrophils \> 1000 / mm3 * Prothrombin ratio \> 50% * Creatinemia \< 150 μmol / L * Total bilirubinemia \< 5 mg / dL * α-fetoprotein \< 200 ng / mL * Performance level of 0 or 1 according to "World Health Organization Performance Status" * Presence of a single hepatocellular carcinoma of less than 3 cm with typical imaging characteristics as recommended by the American Association for the Study of Liver Diseases (AASLD) * Patient with an indication of percutaneous tumor ablation (radiofrequency or microwave) under ultrasound or tomodensitometric identification * Absence of heart failure (Left Ventricular Ejection Fraction (LVEF) \> 50%) * Women of childbearing age, using an effective method of contraception for the duration of treatment and at least 3 months after stopping the treatment. * Male using an effective method of contraception throughout the treatment and at least 3 months after stopping the treatment Exclusion Criteria: * Presence on the initial imaging assessment of a macroscopic vascular invasion (portal or hepatic vein) * Presence on initial imaging assessment of extrahepatic localization of hepatocellular carcinoma * Presence of another untreated cancer * Patients who previsouly received sphincterotomy or bilio-digestive anastomosis * Contraindication to performing a general anesthesia * Contraindication to performing an MRI scan * Allergy to anthracyclines, iodine or gadolinium * Contraindication to the injection of gadolinium-based contrast media. * Contraindication to iodinated contrast agents * Contraindication to Idarubicin (hypersensitivity to the active substance or excipients, severe heart disease, severe arrhythmia, severe renal or hepatic impairment, yellow fever vaccine or any other live attenuated vaccine for 6 months after discontinuation of chemotherapy, persistent myelosupressure, previous treatments with idarubicin and / or other anthracyclines or anthracenediones at maximum cumulative doses, mucositis, breastfeeding, uncontrolled infections, severe heart failure, myocardial infarction less than 6 months old). * Contraindication to Lipiodol (Hypersensitivity, Hyperthyroidism, traumatic lesions, haemorrhage or recent bleeding) * Patients who have already received or exceeded the recommended cumulative dose for anthracyclines (Idarubicin = 150 mg / m²) * Patients who cannot temporarily stop their anticoagulant treatment or anti-platelet agent for the duration of the procedure * Failure of endoscopic eradication of oesophageal varices of grade \> 1 * Inability to adhere to the protocol * Simultaneous participation to another clinical trial * Patients not covered by health insurance
References
Publications (0)
Data not yet available
No reference posted for this study.