Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

Chemoembolization with doxorubicin-loaded BioPearl™ microspheres

First, an angiography of the celiac trunk, superior mesenteric artery and hepatic artery will be obtained by using a peripheral arterial approach.

Arterial embolization will be performed through catheterization of intrahepatic arteries, as selectively as possible (tumor feeders, subsegmental, segmental). The size of the microcatheter must be consistent with the size of BioPearl™ microspheres used. Microspheres of 200 µm will be be used. They will be loaded with the appropriate dose of doxorubicin injectable solution, mixed with the contrast media and distributed according to the location of the HCC lesions. The endpoint of the procedure will be achieved end when stasis of the feeders is achieved.

Chemoembolization

Gontran Verset, MD

Geert Maleux, MD

Luc Defreyne, MD

The primary objective of the study is to confirm safety and efficacy of BioPearl™ microspheres loaded with doxorubicin in the treatment of patients with unresectable hepatocellular carcinoma (HCC).

This is a prospective, single arm, multi-centre, post-market study to further assess safety and efficacy in 20 unresectable HCC patients treated with Doxorubicin loaded BioPearl™ microspheres.

After the treatment procedure, all patients will undergo clinical follow-up until disease progression and/or next treatment option after which patients will be followed for survival. Patients will be followed up to a maximum of 3 years.

BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.

BioPearl™ Microspheres Loaded With Doxorubicin to Treat Patients With Unresectable HCC: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.

Safety by monitoring and evaluating all grade 3-4-5 adverse events related with procedure or study device

Tumor response rate assessed by mRECIST criteria

Ability to reach stasis in the treated tumor feeding arteries during chemoembolization procedure

Time from treatment to progression of the treated lesion according to mRECIST criteria

Time from treatment to un-TACEable progression of the treated lesion according to EASL criteria

Time from treatment to progression anywhere in the liver according to mRECIST criteria or death from any cause

Time from treatment to progression in the liver or outside the liver or death from any cause

Time from treatment until death from any cause

Best response of treated tumor(s) recorded during the course of the study according to mRECIST criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.	NCT04231929	Hepatocellular ...	Chemoembolizati...	18 Years -	Terumo Europe N.V.
BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.	NCT04231929	Hepatocellular ...	Chemoembolizati...	18 Years -	Terumo Europe N.V.

Spots Global Cancer Trial Database for biopearl®

Every month we try and update this database with for biopearl® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for biopearl®

Every month we try and update this database with for biopearl® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for biopearl® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.