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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004859-22 | EudraCT Number | ||
| UF 9888 | Other Identifier | Montpellier University Hospital |
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Enrollement rythm low, funding body decision.
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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idarubicin and Lipiodol | Drug | Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants presenting a disease control at 4 months | The primary outcome is to evaluate the disease control rate (partial, complete or stable response) 4 months after the first cycle of chemo-lipiodol using mRECIST criteria. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03 | Safety defined by NCI-CTCAE version 4.03 published 14 june 2010 | 12 months |
| Objective response rate of chemo-lipiodol | Objective response rate according to mRECIST at 6 months after the first cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris GUIU | Montpellier University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49933 | France | |||
| CHU de Dijon |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D015255 | Idarubicin |
| D004998 | Ethiodized Oil |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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The purpose of this study is to assess efficacy and tolerance of hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol for treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.
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No masking is used. All involved know the identity of the intervention assignment.
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| 6 months |
| best response at 6 months after the first cycle of chemo-lipiodol according to mRECIST | The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol | 6 months |
| Overall survival | Overall survival at 12 months after the first cycle of chemo-lipiodol | 12 months |
| Quality of life questionnaire (QLQ) QLQ-C30 | Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol (QLQ-C30). Subscale minimum score is egal to 1 (not at all) and maximum score is egal to 4 (very much). The maximal score correspond to a better quality of life. Subscales are summed to compute a total score. | 12 months |
| Dijon |
| 21079 |
| France |
| CHU de Montpellier | Montpellier | 34295 | France |
| CHU de Nice | Nice | 06202 | France |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |