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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemo-lipiodol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zavedos® | Drug |
| ||
| Blood samples |
| Measure | Description | Time Frame |
|---|---|---|
| tolerance: toxicity will be evaluated according to the NCI CTC AE version 4.03 scale to determine the limiting dose | 7 weeks after the 2 injections |
| Measure | Description | Time Frame |
|---|---|---|
| Study the pharmacokinetics of idarubicin in this delivery method | 24 months | |
| Evaluate overall survival | 24 months | |
| Evaluate progression-free survival |
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Inclusion criteria:
Histologically-proven hepatocellular carcinoma or carcinoma meeting validated non-invasive criteria (EASL, AASLD)
Exclusion criteria:
Patients who can benefit from curative treatment (surgical resection, liver transplant or treatment via percutaneous destruction)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Dijon | Dijon | 21079 Cedex | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29427728 | Result | Guiu B, Jouve JL, Schmitt A, Minello A, Bonnetain F, Cassinotto C, Piron L, Cercueil JP, Loffroy R, Latournerie M, Wendremaire M, Lepage C, Boulin M. Intra-arterial idarubicin_lipiodol without embolisation in hepatocellular carcinoma: The LIDA-B phase I trial. J Hepatol. 2018 Jun;68(6):1163-1171. doi: 10.1016/j.jhep.2018.01.022. Epub 2018 Feb 8. |
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|
| 24 months |
| Evaluate time to progression | 24 months |
| Evaluate the rate of objective response | 24 months |
| ID | Term |
|---|---|
| D015255 | Idarubicin |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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