RecruitingNot ApplicableNCT05911633

BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)

BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC): Prospective, Single Arm, Multi-center, Post-Market Clinical Follow-up (PMCF) Study


Sponsor

Terumo Europe N.V.

Enrollment

50 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of the study is to confirm safety and technical success of BioPearl™ microspheres loaded with Doxorubicin in the treatment of unresectable hepatocellular carcinoma (HCC). The secondary objective of the study is to investigate the efficacy of BioPearl™ microspheres loaded with Doxorubicin in the treatment of subjects with unresectable HCC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing BioPearl microspheres — tiny beads loaded with chemotherapy (doxorubicin) — delivered directly into the blood vessels feeding a liver tumor. This approach tries to kill the tumor while limiting side effects to the rest of the body. **You may be eligible if...** - You are 18 or older - You have confirmed liver cancer (hepatocellular carcinoma) - Your tumor(s) are under 5 cm and meet specific size criteria (up-to-7 rule) - Your liver is still functioning reasonably well (Child-Pugh A or B7) - Surgery or ablation is not a suitable option for you **You may NOT be eligible if...** - Your cancer has spread outside the liver to other organs - You have very poor liver function - You have had a liver transplant or previous similar treatment 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEBioPearl™

TACE


Locations(10)

CUB Hôpital Erasme

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Beaujon Hospital

Clichy, France

CHU Grenobles (Hôpital Michallon)

La Tronche, France

Paul-Brousse Hospital

Villejuif, France

SLK-Kliniken Heilbronn

Heilbronn, Germany

University Hospital Tübingen

Tübingen, Germany

Fondazione IRCCS Instituto Tumori

Milan, Italy

Fondazione Policlinico Universitario A. Gemelli

Rome, Italy

Città della Salute e della Scienza di Torino

Turin, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05911633


Related Trials