Radioactive oil injection may keep liver cancer at bay
NCT ID NCT00116454
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tested whether a single injection of radioactive lipiodol (Lipiocis) into the liver artery could prevent hepatocellular carcinoma from coming back after surgery or ablation. The study enrolled 73 adults with cirrhosis and one or two liver tumors that had been successfully treated. The goal was to see if the treatment reduced tumor recurrence over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radioactive lipiodol (Lipiocis)
- What this could lead to
- If it works, this could reduce the chance of liver cancer coming back after initial treatment, potentially improving long-term survival.
- What could go wrong
- This is a small, completed trial with only 73 participants, so results may not apply broadly. The treatment involves radiation and may cause liver toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
73 people
The number who actually took part.
- Start date
-
Jul 2005
- Finished
-
Aug 2013
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Service d'Hépatologie Hôpital Saint Antoine
Paris, 75012, France
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