Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-02
Brief Title:
Lenvatinib Plus DEB-TACE and HAIC vs Lenvatinib Plus DEB-TACE for Large HCC With PVTT
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
A Multicentre Randomised Controlled Study of Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy With FOLFOX Regimen Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma Larger Than 7 cm With Portal Vein Tumor Thrombosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization TACE with drug-eluting beads DEB-TACE and hepatic artery infusion chemotherapy HAIC with FOLFOX regemen LenDEB-TACEHAIC versus lenvatinib plus DEB-TACE LenDEB-TACE for large hepatocellular carcinoma 7cm with portal vein tumor thrombosis PVTT
Detailed Description:
This is a multicenter prospective and randomized study to evaluate the efficacy and safety of LenDEB-TACEHAIC compared with LenDEB-TACE for unresectable large HCC 7cm with PVTT
178 patients with large HCC 7cm and PVTT will be enrolled in this study The patients will receive either LenDEB-TACEHAIC or LenDEB-TACE using an 11 randomization scheme In the LenDEB-TACEHAIC arm the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs oxaliplatin fluorouracil and leucovorin FOLFOX-based regimen will be intra-arterially administered though the microcatheter DEB-TACEHAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team In the LenDEB-TACE arm patients will be treated with DEB-TACE alone TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team In both arms lenvatinib 12mg body weight 60kg or 8mg body weight 60kg PO qd will be started within 7 days after the first DEB-TACEHAICDEB-TACE
The primary end point of this study is time to progression TTP The secondary endpoints are tumor response objective response rate and disease control rate overall survival OS and adverse events AEs
178 patients with large HCC 7cm and PVTT will be enrolled in this study The patients will receive either LenDEB-TACEHAIC or LenDEB-TACE using an 11 randomization scheme In the LenDEB-TACEHAIC arm the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs oxaliplatin fluorouracil and leucovorin FOLFOX-based regimen will be intra-arterially administered though the microcatheter DEB-TACEHAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team In the LenDEB-TACE arm patients will be treated with DEB-TACE alone TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team In both arms lenvatinib 12mg body weight 60kg or 8mg body weight 60kg PO qd will be started within 7 days after the first DEB-TACEHAICDEB-TACE
The primary end point of this study is time to progression TTP The secondary endpoints are tumor response objective response rate and disease control rate overall survival OS and adverse events AEs
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