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Spots Global Cancer Trial Database for Hepatic IA Therapy in Stage B or Limited Stage C Hepatoma (HCC)

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Trial Identification

Brief Title: Hepatic IA Therapy in Stage B or Limited Stage C Hepatoma (HCC)

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

Study ID: NCT04601428

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National Cheng Kung University Hospital (NCKUH), Tainan City, North Dist., Taiwan

Koo Foundation Sun Yat-Sen Cancer Center (KFSYSCC), Taipei, Pei-Tou Dist., Taiwan

National Taiwan University Hospital (NTUH), Taipei city, Zhongzheng Dist., Taiwan

KFSYSCC, Taipei, , Taiwan

Contact Details

Name: Paul Weiden, M.D.

Affiliation: KFSYSCC consultant

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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