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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
BioPearl™
DeviceTACE
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Single armOther 1 intervention
Trial outcomes
Primary outcomes
1
Safety: by evaluating all procedural or study device related grade 3-4-5 adverse events (AEs)
By evaluating all procedural or study device related grade 3-4-5 adverse events (AEs) during a period of 4 weeks post initial treatment as per local investigator assessment
Time frame
Day 292
Technical success
Ability to reach near stasis in the treated tumor feeding arteries during chemoembolization procedure
Time frame
Day 1Secondary outcomes
1
Tumor response rate
Assessed by mRECIST (modified Response Evaluation Criteria in Solid Tumors) criteria at 4 weeks and every 3 months as per local investigator assessment
Time frame
18 months2
Progression Free Survival (PFS)
Defined as time from the treatment to disease progression according to mRECIST criteria or death from any cause, whichever occurs first as per local investigator assessment
Time frame
18 months3
Time to progression
Defined as time from treatment to progression according to mRECIST criteria as per local investigator assessment
Time frame
18 months4
Duration of response
According to mRECIST as per local investigator assessment
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov