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Hepatocellular Carcinoma Non-resectableBIOPEARL-ONENCT05911633

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

A study testing BioPearl™ in people with Hepatocellular Carcinoma Non-resectable, run by Terumo Europe N.V. at 10 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma Non-resectable
What is being tested?
BioPearl™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
10 sitesin 4 countries
Study dates
27 Feb 2024to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Subject with treatment failure/recurrence after a prior resection/ablation is permitted, with the exception of recurrence in the segment of a prior thermal ablation
  • WHO (World Health Organization) or ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1
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  • Subject deemed treatable in one session for initial treatment
  • Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A)
  • Total bilirubin ≤ 2.0 mg/dl
  • Adequate bone marrow function: Hemoglobin ≥ 9g/dl, absolute neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L
  • Subject with no ascites or with minor ascites controlled by sodium dietary restrictions (subject receiving diuretic treatment or paracentesis is not eligible)
  • Adequate renal function: serum creatinine < 1.5 X ULN (Upper Limit of Normal)
  • Subject has provided written informed consent
  • Subjects of childbearing/reproductive potential should use adequate birth control measures, during the study treatment period until survival follow-up

Who cannot join

  • 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
  • Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy
  • Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status >1)
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  • History of another primary tumor. Exceptions include:
  • Malignancy treated with curative intent ≥ 5 years before inclusion and with no known active disease
  • Malignancy which occurred < 5 years before, not active and not expected to recur or be clinically relevant in the next 5 years
  • Subject with history of biliary tree disease or biliary dilatation
  • Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated
  • Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media)
  • Any other contraindication for embolization procedure or Doxorubicin treatment
  • Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  • Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials
  • In the Investigator's opinion subject has (a) co-morbid condition(s) that could limit the subject's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  • Pregnant or breast-feeding woman

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

France3 sites

  • Beaujon Hospital

    Clichy

  • CHU Grenobles (Hôpital Michallon)

    La Tronche

  • Paul-Brousse Hospital

    Villejuif

Other trials in France

Italy3 sites

  • Fondazione IRCCS Instituto Tumori

    Milan

  • Fondazione Policlinico Universitario A. Gemelli

    Rome

  • Città della Salute e della Scienza di Torino

    Turin

Other trials in Italy

Belgium2 sites

  • CUB Hôpital Erasme

    Brussels

  • UZ Leuven

    Leuven

Other trials in Belgium

Germany2 sites

  • SLK-Kliniken Heilbronn

    Heilbronn

  • University Hospital Tübingen

    Tübingen

Other trials in Germany

About this study

Official title: 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

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.

Read the detailed description

This is a prospective, single arm, multi-centre, post-market clinical follow-up study to further assess safety and efficacy in 50 subjects with unresectable HCC treated with BioPearl™ microspheres loaded with Doxorubicin. All subjects will undergo clinical follow-up until disease progression and/or next treatment option, after which subjects will be followed for survival. Subjects will be followed up to a maximum of 18 months. An intermediate analysis will take place during enrollment period on safety and technical success to support regulatory requirements.

Being tested
BioPearl™
Keywords
Hepatocellular Carcinoma Non-resectable, HCC, TACE, Chemoembolization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioPearl™Device

    TACE

Study groups in NCT05911633
Study groupRoleWhat they receive
Single armOtherTransarterial Chemo Embolization (TACE) with BioPearl™ microspheres loaded with Doxorubicin
Receives: Device: BioPearl™

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 29

  2. Technical success

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

    Measured: Day 1

Secondary outcomes (6)

  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

    Measured: 18 months

  2. 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

    Measured: 18 months

  3. Time to progression

    Defined as time from treatment to progression according to mRECIST criteria as per local investigator assessment

    Measured: 18 months

  4. Duration of response

    According to mRECIST as per local investigator assessment

    Measured: 18 months

  5. Best response

    Defined as best response recorded during the study according to mRECIST criteria as per local investigator assessment

    Measured: 18 months

  6. Survival Rate

    up to 18 months

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start27 Feb 2024
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05911633
Sponsor's protocol ID
T144E3
Acronym
BIOPEARL-ONE
Status last verified
Oct 2026
First submitted
26 May 2023
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Verset G, Iezzi R, Bargellini I, Bucalau AM, Pereira P, Groezinger G, Spreafico C, Maleux G. BioPearl doxorubicin microspheres for unresectable HCC: a prospective, single-arm, multicenter study: BIOPEARL-ONE. Future Oncol. 2025 Feb;21(5):557-564. doi: 10.1080/14796694.2024.2446137. Epub 2024 Dec 30.

    PubMed 39972606

Questions about this trial

What is this clinical trial studying?

A study testing BioPearl™ in people with Hepatocellular Carcinoma Non-resectable, run by Terumo Europe N.V. at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France, Italy, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: by evaluating all procedural or study device related grade 3-4-5 adverse events (AEs) (time frame: Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05911633, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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