Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405061
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-25
Brief Title:
Evaluation of Effectiveness and Safety of HAIC in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
A Prospective Single-arm Multicenter Phase II Clinical Study of Hepatic Arterial Perfusion Chemotherapy FOLFOX in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma
Status:
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:
Primary liver cancer mainly consists of three different pathologic types hepatocellular carcinoma intrahepatic cholangiocarcinoma and hybrid HCC-ICC of which HCC accounts for 90 According to GLOBOCAN 2018 data liver cancer is the sixth most prevalent tumor in the world with about 841100 new liver cancer cases and 781600 deaths per year globally which is the second leading cause of tumor deaths in men worldwide China is a high incidence area of liver cancer accounting for about 50 of the global incidence and deaths
The treatment of HCC varies according to disease stage which is based on the BCLC classification system Child-Pugh liver function rating and extent of disease Approximately 30 of HCC cases are diagnosed in the early stages ie BCLC stage 0 or A and the main treatment options include surgical resection ablation techniques and liver transplantation However the 5-year recurrence rate remains as high as 70 The recommended treatment for intermediate stage HCC ie BCLC stage B is hepatic artery intervention ie transarterial chemoembolization TACE but the scope of applicability is limited due to concomitant disease and liver impairment factors some patients do not derive a survival benefit from it and patients ultimately progress after treatment and are no longer suitable for further TACE
In recent years the multi-drug combination therapy of systemic drugs combined with local therapy has also been gradually adopted and studies have reported the feasibility of target drugs combined with ICI TACE or HAIC for the treatment of unresectable hepatocellular carcinoma The therapeutic aim of Adebrelimab SHR-1316 is to inhibit tumor growth by specifically blocking the binding of PD-1 to PD-L1 and terminating the immunosuppressive signals generated by this receptor on T cells so that T cells can re-recognize tumor cells and produce killing effects on them
This study proposes an evaluation to explore the efficacy and safety of irinotecan liposome-based hepatic arterial perfusion chemotherapy FOLFIRI in combination with adebrelimab and bevacizumab for the treatment of potentially resectable hepatocellular carcinoma
The treatment of HCC varies according to disease stage which is based on the BCLC classification system Child-Pugh liver function rating and extent of disease Approximately 30 of HCC cases are diagnosed in the early stages ie BCLC stage 0 or A and the main treatment options include surgical resection ablation techniques and liver transplantation However the 5-year recurrence rate remains as high as 70 The recommended treatment for intermediate stage HCC ie BCLC stage B is hepatic artery intervention ie transarterial chemoembolization TACE but the scope of applicability is limited due to concomitant disease and liver impairment factors some patients do not derive a survival benefit from it and patients ultimately progress after treatment and are no longer suitable for further TACE
In recent years the multi-drug combination therapy of systemic drugs combined with local therapy has also been gradually adopted and studies have reported the feasibility of target drugs combined with ICI TACE or HAIC for the treatment of unresectable hepatocellular carcinoma The therapeutic aim of Adebrelimab SHR-1316 is to inhibit tumor growth by specifically blocking the binding of PD-1 to PD-L1 and terminating the immunosuppressive signals generated by this receptor on T cells so that T cells can re-recognize tumor cells and produce killing effects on them
This study proposes an evaluation to explore the efficacy and safety of irinotecan liposome-based hepatic arterial perfusion chemotherapy FOLFIRI in combination with adebrelimab and bevacizumab for the treatment of potentially resectable hepatocellular carcinoma
Detailed Description:
None
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