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Anti-tumor antibiotic

Surefire Infusion System for Liver Cancer

Q: Does this experiment represent a landmark in scientific research?

Since its first investigation in 1997, which was sponsored by Alfacell and involved 300 patients, Surefire has gone through extensive clinical trials. Currently, the drug is undergoing Phase 3 approval with 361 active studies conducted across 1952 cities and 66 countries.

Q: Are there any current openings to participate in this trial?

Indeed, the information posted on clinicaltrials.gov indicates that this investigation is actively searching for participants. The trial began recruiting in July of 2016 and was most recently updated on January 10th 2022. In total, they are looking to recruit 10 patients from one medical centre.

Q: What is the current sample size for this experiment?

Yes, the clinicaltrials.gov registry verifies that this trial is still seeking participants. The study was first posted on July 1st 2016 and recently updated on January 10th 2022; they are hoping to enroll 10 individuals at a single site.

Q: Have any other investigations been conducted using Surefire as a research tool?

Presently, 361 trials are actively running for Surefire. Of those studies, 120 have reached the third stage of clinical research. While most experiments take place in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> City itself, there is a total of 24358 locations administering this medication across America.

Q: Is there an age limitation for participants in this trial?

To enroll in this medical trial, the patient must be between 18 and 75 years of age. Alternatively, there are 111 studies available for those under 18-years old and 516 trials open to patients above 65.

Q: What health conditions generally warrant the utilization of Surefire?

Hodgkin's <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> is commonly treated using Surefire, and it also shows efficacy when used to combat carcinoma, bronchogenic tumours, neuroblastomas (NBs), and Sezary Syndrome.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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

Secondary outcome measures

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)

+1 more

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

~7940

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,976 Total Patients Enrolled

5 Trials studying Liver Cancer

5,715 Patients Enrolled for Liver Cancer

Dmitry Rabkin, MD, PhDPrincipal Investigator - Brigham and Women's Hospital

Dana-Farber Cancer Institute

Media Library

Doxorubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02853500 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met to join in this research endeavor?

"This clinical trial is looking for 10 adults aged 18 to 75 who have been diagnosed with liver cancer. The ideal candidate will meet the following criteria: intermediate-stage HCC (BCLC class B) not eligible for curative treatment, Child-Pugh A or B status, tumors occupying <50% of their entire liver, ECOG performance score ≤2 and a life expectancy greater than 12 months. Note that this study does not include pediatric patients due to the low prevalence rate of this disease in children."

Answered by AI

Does this experiment represent a landmark in scientific research?

"Since its first investigation in 1997, which was sponsored by Alfacell and involved 300 patients, Surefire has gone through extensive clinical trials. Currently, the drug is undergoing Phase 3 approval with 361 active studies conducted across 1952 cities and 66 countries."

Answered by AI

Are there any current openings to participate in this trial?

"Indeed, the information posted on clinicaltrials.gov indicates that this investigation is actively searching for participants. The trial began recruiting in July of 2016 and was most recently updated on January 10th 2022. In total, they are looking to recruit 10 patients from one medical centre."

Answered by AI

What is the current sample size for this experiment?

"Yes, the clinicaltrials.gov registry verifies that this trial is still seeking participants. The study was first posted on July 1st 2016 and recently updated on January 10th 2022; they are hoping to enroll 10 individuals at a single site."

Answered by AI

Have any other investigations been conducted using Surefire as a research tool?

"Presently, 361 trials are actively running for Surefire. Of those studies, 120 have reached the third stage of clinical research. While most experiments take place in New york City itself, there is a total of 24358 locations administering this medication across America."

Answered by AI

Is there an age limitation for participants in this trial?

"To enroll in this medical trial, the patient must be between 18 and 75 years of age. Alternatively, there are 111 studies available for those under 18-years old and 516 trials open to patients above 65."

Answered by AI

What health conditions generally warrant the utilization of Surefire?

"Hodgkin's lymphoma is commonly treated using Surefire, and it also shows efficacy when used to combat carcinoma, bronchogenic tumours, neuroblastomas (NBs), and Sezary Syndrome."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies

Dmitry Rabkin, MD 2016. "Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02853500.

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