Treatment of Cirrhosis-related Hepatocellular Carcinoma With the Intrahepatic Arterial Injection … (NCT02028949) | Clinical Trial Compass
CompletedPhase 1
Treatment of Cirrhosis-related Hepatocellular Carcinoma With the Intrahepatic Arterial Injection of an Emulsion of Lipiodol and Idarubicin (Zavedos®): Phase I Study
France15 participantsStarted 2012-11-22
Plain-language summary
Unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (HCC) has a poor prognosis as there are no recommended curative treatments. Chemoembolisation is the most widely used treatment in these patients, but this technique can prove to be toxic. intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective therapeutic approach, without deteriorating liver function.
The rationale for this treatment can be resumed as follows:
* HCC are vascularised via the hepatic artery system
* The IHA perfusion of anthracyclines leads to high elimination via the liver with low systemic concentrations
* The absence of embolisation reduces toxicity
* the toxiciity profile of idarubicin is well known and the drug is widely used for the IV treatment of leukemia
* idarubicin is the most cytotoxic drug for tumor cell lines.
* The in vitro cytotoxicity of idarubicin is 100% at low concentrations
* Lipiodol can stay in contact with tumor tissue for several weeks after injection and act as a vector for the drug
* The idarubicin-lipiodol is more stable than lipidol emulsions usually given by intraarterial injection
* The emulsion is more stable with idarubicin than with other anticancer molecules
* Sequential inclusion in accordance with the "continual reassessment method" makes it possible to increase inclusions at a target toxicity level while reducing inclusions at doses that are too low or too toxic The aim of the treatment is to improve survival.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
Histologically-proven hepatocellular carcinoma or carcinoma meeting validated non-invasive criteria (EASL, AASLD)
* Child-Pugh A OR B7 cirrhosis
* General health status WHO 0.1
* Platelets \> 50 000/mm3, Polynuclear neutrophils \> 1000/mm3
* Creatininemia \< 1.5 times upper limit of normal
* LVEF by MUGA scan or US \> 50 %
* Age \> 18 years
* Signed informed consent
* For women child-bearing age, an effective means of contraception
Exclusion criteria:
Patients who can benefit from curative treatment (surgical resection, liver transplant or treatment via percutaneous destruction)
* Non-cirrhotic liver
* Cirrhosis Child B8 or B9 or C
* Extrahepatic metastases (pulmonary micronodules \< 7mm are not considered a contra-indication)
* Digestive hemorrhage within the previous month
* Patient on anticoagulants
* Pregnant women
* Uncontrolled infection
* Hypersensitivity to anthracyclines
* Hypersensitivity to iodine contrast agents
* Patient under guardianship or ward of court
* Patients who have already received the recommended cumulative dose of anthracycline (93 mg/m2 for idarubicin, 140 mg/m2 for mitoxantrone, 550 mg/m2 for doxorubicin, 600 mg/m2 for daunorubicin, 900 mg/m2 for epirubicin)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
tolerance: toxicity will be evaluated according to the NCI CTC AE version 4.03 scale to determine the limiting dose