Liver cancer trial tests new chemo combo without embolization
NCT ID NCT03727633
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial tested a liver-directed chemotherapy using idarubicin mixed with lipiodol (a fatty contrast agent) injected directly into the liver artery. The goal was to see if this could control non-spreading liver cancer in 44 patients with cirrhosis. The study was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- idarubicin and lipiodol
- What this could lead to
- If it works, this could offer a new way to control liver cancer in patients who cannot have surgery or other standard treatments.
- What could go wrong
- This is an early phase 2 trial with only 44 participants, and it was terminated early. The treatment may not control the disease or could cause side effects like liver damage or low blood counts.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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44 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Jan 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * 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
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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
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CHU d'Angers
Angers, 49933, France
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CHU de Dijon
Dijon, 21079, France
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CHU de Montpellier
Montpellier, 34295, France
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CHU de Nice
Nice, 06202, France
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