IA Therapy for Liver Cancer

Phase < 1

Recruiting

Research Sponsored by Koo Foundation Sun Yat-Sen Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up by mri on day 50 and then every 3 months for an average of one year.

Awards & highlights

Study Summary

This trial will investigate a new agent that selectively targets and blocks only the blood vessels of HCC tumors, in hopes of better and more efficient treatment.

Who is the study for?

Adults diagnosed with intermediate-stage B or limited advanced-stage C liver cancer (HCC) who are not candidates for curative surgery, liver transplant, or ablation. They should have an ECOG performance status of ≤1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature. Participants must have adequate organ function as shown by specific blood tests and agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing a new intra-arterial therapy called CSR02-Fab-TF specifically targeting the blood vessels feeding HCC tumors while sparing normal liver tissue. This approach aims to cut off the tumor's blood supply more selectively than current methods, potentially leading to better outcomes for patients with extensive tumors not suitable for surgical removal.See study design

What are the potential side effects?

While the trial description does not list specific side effects, similar treatments can cause complications like fever, abdominal pain, nausea, changes in liver function tests, and potential allergic reactions to contrast media used during IA procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ by mri on day 50 and then every 3 months for an average of one year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~by mri on day 50 and then every 3 months for an average of one year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and by mri on day 50 and then every 3 months for an average of one year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HCC blood flow

Incidence and severity of adverse events from intra-arterial infusion of CSR02-Fab-TF in patients with hepatoma only or largely confined to the liver, and resistant/recurrent after prior therapy

Secondary outcome measures

Intra-Arterial Infusions