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RecruitingEarly Phase 1NCT04601428

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

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

Sponsor

Koo Foundation Sun Yat-Sen Cancer Center

Enrollment

43 participants

Start Date

Jan 26, 2021

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma (HCC)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a liver-directed treatment called hepatic intra-arterial therapy — where treatment is delivered directly through the blood vessels feeding the liver — for people with intermediate or select advanced-stage liver cancer (hepatocellular carcinoma or HCC) who have not responded to prior liver treatments or systemic therapies. **You may be eligible if...** - You are 18 or older - You have confirmed liver cancer (HCC) at intermediate stage (Barcelona Stage B) or limited advanced stage (Stage C) - Your cancer has not responded to previous liver-directed or systemic treatments, or has progressed - You are not a candidate for surgery, liver transplant, or ablation - Your overall health/functional status is good (ECOG 0–1) - Your liver function and blood tests are within acceptable ranges **You may NOT be eligible if...** - Your cancer is too advanced or widely spread - Your liver function is severely impaired - Your health status is too poor to undergo the procedure safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIA therapy of HCC with CSR02-Fab-TF

Intra-Arterial Infusion of CSR02-Fab-TF

Locations(4)

National Cheng Kung University Hospital (NCKUH)

Tainan, North Dist., Taiwan

Koo Foundation Sun Yat-Sen Cancer Center (KFSYSCC)

Taipei, Pei-Tou Dist., Taiwan

National Taiwan University Hospital (NTUH)

Taipei, Zhongzheng Dist., Taiwan

KFSYSCC

Taipei, Taiwan

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NCT04601428

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