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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
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.
CUB Hôpital Erasme
Brussels, Belgium
UZ Gent
Ghent, Belgium
University Hospital Leuven
Leuven, Belgium
Incidence of grade 3-4-5 adverse events related with procedure or study device
Safety by monitoring and evaluating all grade 3-4-5 adverse events related with procedure or study device
Time frame: 4 weeks
Tumor response
Tumor response rate assessed by mRECIST criteria
Time frame: 4 weeks
Tumor response
Tumor response rate assessed by mRECIST criteria
Time frame: 12 weeks
Technical success
Ability to reach stasis in the treated tumor feeding arteries during chemoembolization procedure
Time frame: 1 day
Time to progression of treated tumor(s)
Time from treatment to progression of the treated lesion according to mRECIST criteria
Time frame: 3 years
Time to un-TACEable progression
Time from treatment to un-TACEable progression of the treated lesion according to EASL criteria
Time frame: 3 years
Hepatic progression free survival
Time from treatment to progression anywhere in the liver according to mRECIST criteria or death from any cause
Time frame: 3 years
Progression free survival
Time from treatment to progression in the liver or outside the liver or death from any cause
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall survival
Time from treatment until death from any cause
Time frame: 3 years
Best overall response
Best response of treated tumor(s) recorded during the course of the study according to mRECIST criteria
Time frame: 3 years