← Back to Search

Anti-tumor antibiotic

Surefire Infusion System for Liver Cancer

N/A

Recruiting

Led By Dmitry Rabkin, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Unresectable HCC, defined by imaging criteria or cytohistologic assessment with TACE as a preferred method of treatment determined by a multidisciplinary Brigham and Women's Hospital / Dana Farber Cancer Institute (BWH/DFCI) Liver Tumor Board

No previous regional treatment

Must not have

Portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice

Hypovascular tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether the Surefire Infusion System can help increase the delivery of chemotherapeutic agents to patients with locally advanced liver cancer.

Who is the study for?

This trial is for adults aged 18-75 with unresectable intermediate stage Hepatocellular Carcinoma (HCC) who haven't had previous regional liver treatments. They should have a life expectancy of over 12 months, acceptable blood counts and organ function, and be able to consent. Pregnant women or those with severe heart, kidney diseases, HIV, brain metastases or certain other conditions are excluded.

What is being tested?

The study tests the Surefire Infusion System's effectiveness in delivering chemotherapy directly to liver tumors during Trans-arterial chemoembolization (TACE). It compares TACE with and without Surefire in patients with locally advanced HCC that can't be surgically removed.

What are the potential side effects?

Potential side effects include reactions to doxorubicin such as nausea, vomiting, hair loss; MRI contrast agents may cause allergic reactions; iodinated contrast agents used could lead to kidney issues. The procedure itself might result in post-embolization syndrome featuring fever, pain and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My liver cancer cannot be removed by surgery and a team of experts recommends TACE.

Select...

I have not had treatments targeting specific body areas.

Select...

My main tumor is larger than 1 cm.

Select...

My liver cancer is at an intermediate stage, not affecting more than half of my liver, and my liver function is relatively good.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My liver cancer has blocked the main vein without causing other veins to enlarge.

Select...

My tumor has poor blood supply.

Select...

I have cancer that has spread to my brain.

Select...

My liver is not working properly.

Select...

I do not have severe heart or kidney diseases.

Select...

I do not have any uncontrolled illnesses.

Select...

I have had treatments like radiation or targeted therapy for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Capillary permeability (Ktrans) calculated by software that analyzes enhancement on post-contrast MRI.

Secondary study objectives

Extravascular extracellular volume fraction (ve) calculated by software that analyzes enhancement on post-contrast MRI.

Plasma volume (vp) calculated by software that analyzes enhancement on post-contrast MRI.

Rate constant (kep)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TACE Procedure With TriNavExperimental Treatment2 Interventions

Patients will receive a single administration of intra-arterial chemotherapy (Doxorubicin) during the TACE procedure via TriNav. * Patients will undergo structural follow-up for a timeframe of one year post treatment * Post-procedural, contrast-enhanced Magnetic Resonance Imaging (MRI) will be performed one month after trial entry, and at regular intervals thereafter for a total of one year to assess tumor response

Group II: TACE Procedure Traditional DeliveryActive Control2 Interventions

Patients will receive a single administration of intra-arterial chemotherapy (Doxorubicin) during the TACE procedure via Traditional Delivery. * Patients will undergo structural follow-up for a timeframe of one year post treatment * Post-procedural, contrast-enhanced Magnetic Resonance Imaging (MRI) will be performed one month after trial entry, and at regular intervals thereafter for a total of one year to assess tumor response

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~8030

0 / 13Eligibility criteria met