Clinical trial · Interventional
Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis
A Randomized and Multicenter Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis
- 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 recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.
Conditions
Conditions (2)
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 |
| Hepatitis, Viral, Human | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 131 I-lipiodol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- lipiocis group
- description
- intra-arterial hepatic administration, one 2200 MBQ dose, duration of treatment 1 week
- interventionNames
- Drug: 131 I-lipiodol
- type
- NO_INTERVENTION
- label
- control group
- description
- group untreated
Primary outcomes (1)
- measure
- to determine if the Lipiocis treatment decreases the % of tumoral recurrence after 24 months, judged on the rise of alpha-fetoprotein and the reappearance of one or more tumours on the hepatic CT scan
- timeFrame
- at 24 Months
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Men or women , aged between 18 and 75 years old * Cirrhosis or chronic hepatitis associated with C, B, delta infection or alcool intake or both and confirmed by liver biopsy * One or two HCC nodules treated by surgical or percutaneous ablation (ethanol, acetic acid 50% or radiofrequency). * The efficacy of the initial curative treatment will be assessed by the following criteria: alpha-fetoprotein concentration \< or equal 25ng/ml, no progression in size of the tumour demonstrated by ultrasonography and no arterial hypervascularization on CT scan imaging Exclusion Criteria: * HIV coinfection associated with a CD count\<200/mm3 and a viral charge\>5000 HIV RNA copies/ml * Documented iodine intolerance * Respiratory insufficiency * Decompensated cirrhosis (Child-Pugh score over 8) * Bilirubin concentration over 51 µmol/l * Portal or hepatic vein thrombosis * Extra-hepatic metastasis * Excessive alcohol intake (over 50g per day) * Blood platelet count below 50000/mm3 * Neutrophil count above 1500/mm3 * Creatininemia over 120µmol/l * Myocardial infarction or rhythm disorders * Psychiatric disease with hospitalization * Previous treatment for hepatocellular carcinoma * Pregnant or breastfeeding * Treatment with interferon and/or ribavirin 3 months before inclusion * Treatment with tamoxifen or somatostatin analogs or systemic chemotherapy
References
Publications (0)
Data not yet available