Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375317
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure
Sponsor:
Yehua Shen
Organization:
Fudan University
Study Overview
Official Title:
A Single-center Single-arm Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy there is currently no standard treatment regimen for second-line therapy this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy not only providing new treatment options for second-line therapy of liver cancer but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib which has significant scientific research significance and clinical value
Detailed Description:
This is A Single-center Single-arm Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy HAIC Combined with PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure
In clinical practice second-line liver cancer treatment still mainly relies on single-agent therapy which may not provide additional clinical benefits for patients On one hand a real-world multicenter study published by ESMO in 2023 showed that the combination of ICIs and TKIs may still have potential efficacy in patients who progress after first-line targeted therapy for advanced liver cancer Secondly the combination of targeted therapy and local hepatic arterial infusion chemotherapy HAIC may provide a new opportunity for patients with advanced liver cancer who progress after targeted therapy On the other hand unlike PD-1 inhibitors PD-L1 inhibitors can block the binding ability of PD-L1 with B71 on the surface of T cells which is advantageous for comprehensive T cell activation At the same time PD-L1 monoclonal antibody only blocks the binding of PD-L1 with PD-1 preserving the function of PD-L2 and avoiding side effects such as interstitial lung disease ILD thus having better safety Therefore this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy
In clinical practice second-line liver cancer treatment still mainly relies on single-agent therapy which may not provide additional clinical benefits for patients On one hand a real-world multicenter study published by ESMO in 2023 showed that the combination of ICIs and TKIs may still have potential efficacy in patients who progress after first-line targeted therapy for advanced liver cancer Secondly the combination of targeted therapy and local hepatic arterial infusion chemotherapy HAIC may provide a new opportunity for patients with advanced liver cancer who progress after targeted therapy On the other hand unlike PD-1 inhibitors PD-L1 inhibitors can block the binding ability of PD-L1 with B71 on the surface of T cells which is advantageous for comprehensive T cell activation At the same time PD-L1 monoclonal antibody only blocks the binding of PD-L1 with PD-1 preserving the function of PD-L2 and avoiding side effects such as interstitial lung disease ILD thus having better safety Therefore this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy
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