Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04601428
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2020-09-29
Brief Title:
Hepatic IA Therapy in Stage B or Limited Stage C Hepatoma HCC
Sponsor:
Koo Foundation Sun Yat-Sen Cancer Center
Organization:
Koo Foundation Sun Yat-Sen Cancer Center
Study Overview
Official Title:
CSR02-Fab-TF as Hepatic Intra-arterial Therapy in Intermediate Stage B or Limited Advanced Stage C Hepatocellular Carcinoma HCC Dose-Escalation Study to Assess Safety and Tolerability
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intra-arterial IA therapy is generally used to treat HCC tumors that are too extensive to excise or treat with potentially curative local therapy IA therapy takes advantage of the fact that the blood supply of HCC comes predominantly from the hepatic artery compared with the surrounding normal liver which is predominantly supplied by portal venous blood The intent is to deprive the HCC of its blood supply leading to the death of the tumor Traditionally various methods have been used to block the HCC blood supply but improvements are needed This study will investigate a new agent designed in the laboratory to block only tumor blood vessels not blood vessels in the normal liver
Detailed Description:
Genetic testing was done to identify differences between HCC tumors and normal liver and a protein PLVAP was shown to be present on the blood vessels of HCC but not on the blood vessels of normal liver An antibody CSR02 was made that recognizes PLVAP and then the Fab portion of that antibody was combined with tissue factor a normal human protein that initiates the clotting cascade The result is a manufactured recombinant protein called CSR02-Fab-TF Preclinical studies in a mouse model showed that infusion of an equivalent mouse protein resulted in the necrosis death of a transplanted human HCC The current study is designed first to identify a safe and optimal dose of CSR02-Fab-TF in patients and then second to determine the response rate of HCC tumors to the IA administration of CSR02-Fab-TF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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