BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTerumo Europe N.V.
About this trial
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 criteria
Qualifiers
Subject is at least 18 years old
Subject with HCC confirmed by histology or according to the latest applicable version of EASL (the European Association for the Study of the Liver) criteria
Subject with tumor(s) < 5 cm and within the up-to-7 criteria: the sum of the diameter of the largest tumor (in cm) and the number of tumors must be ≤ 7.0
Subject with BCLC (Barcelona Clinic Liver Cancer) Stage A or B classification who is not a candidate for curative treatment at the time of study inclusion
Disqualifiers
Subject previously treated with any systemic therapy for HCC
Subject previously treated with intra-arterial loco-regional therapy for HCC
Eligible for curative treatment at the time of study inclusion
Recurrence in the segment of a prior thermal ablation
Trial design
Treatments tested in this trial
- BioPearl™
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov