Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05901194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-13
First Post:
2023-05-26
Brief Title:
Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Study of the Benefit of Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma HCC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ta-Len-Tra
Brief Summary:
Currently in France hepatocellular carcinoma HCC represents over 30 of indications of liver transplantation LT 500 casesyear Chemoembolization TACE is the most commonly used bridge treatment in those patients estimate 60 These patients will present with a complete response in only 60 of the cases 180 patients per year in France and failure in 40 of the cases 120 patients per year in France
A systemic treatment using lenvatinib might provide a benefit in patients presenting with a non-resectable HCC in waiting list for LT and with a TACE failure ie those with an active disease and a partial response or a stable disease or a progressive disease on imaging data in particular when AFP remains significantly increased after 2 TACE by decreasing dropout rate before LT and decreasing recurrence rate post-LT without new safety signal
A systemic treatment using lenvatinib might provide a benefit in patients presenting with a non-resectable HCC in waiting list for LT and with a TACE failure ie those with an active disease and a partial response or a stable disease or a progressive disease on imaging data in particular when AFP remains significantly increased after 2 TACE by decreasing dropout rate before LT and decreasing recurrence rate post-LT without new safety signal
Detailed Description:
The investigators identified a sub-group of patients with non resectable HCC that could benefit from a systemic neoadjuvant medical strategy before liver transplantation LT In these patients the investigators propose to add oral systemic chemotherapy with lenvatinib as a bridgingdownstaging therapeutic approach until LT
In the case of at least partial response or stability under lenvatinib and within AFP score of 2 the patients will be transplanted and lenvatinib will be stopped on the day or the day before LT depending on the availability of the graft
In the case of disease progression the patient will stop prematurely the lenvatinib treatment and will be treated according to usual practices The patients eligibility for LT will be assessed according to usual practices
In the case of at least partial response or stability under lenvatinib and within AFP score of 2 the patients will be transplanted and lenvatinib will be stopped on the day or the day before LT depending on the availability of the graft
In the case of disease progression the patient will stop prematurely the lenvatinib treatment and will be treated according to usual practices The patients eligibility for LT will be assessed according to usual practices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-000998-31 | EUDRACT_NUMBER | None | None |