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

NCT05911633 | Recruiting DMC

• 1 other identifier: T144E3
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 10

Brief 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). 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.

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular Carcinoma Non-resectable; HCC; TACE; Chemoembolization

Outcome Measures

Primary Outcomes (2)

• 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

  Day 29

• Technical success

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

  Day 1

Secondary Outcomes (6)

• Tumor response rate

  18 months

• Progression Free Survival (PFS)

  18 months

• Time to progression

  18 months

• Duration of response

  18 months

• Best response

  18 months

Study Arms (1)

Single arm

OTHER

Transarterial Chemo Embolization (TACE) with BioPearl™ microspheres loaded with Doxorubicin

Device: BioPearl™

Interventions

BioPearl™ DEVICE

TACE

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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
• 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

You may not qualify if:

• Subject previously treated with any systemic therapy for HCC
• Subject previously treated with intra-arterial loco-regional therapy for HCC
• 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)
• History of another primary tumor. Exceptions include:
• B. 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

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (10)

CUB Hôpital Erasme

Brussels, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

Beaujon Hospital

Clichy, France

RECRUITING

CHU Grenobles (Hôpital Michallon)

La Tronche, France

NOT YET RECRUITING

Paul-Brousse Hospital

Villejuif, France

RECRUITING

SLK-Kliniken Heilbronn

Heilbronn, Germany

RECRUITING

University Hospital Tübingen

Tübingen, Germany

RECRUITING

Fondazione IRCCS Instituto Tumori

Milan, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli

Rome, Italy

RECRUITING

Città della Salute e della Scienza di Torino

Turin, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 39972606 DERIVED

Study Officials

• Marie-Pierre Dewez

  Terumo Europe EMCD

  STUDY DIRECTOR

Central Study Contacts

Tamara Sals

CONTACT

+32 483 53 41 06; tamara.sals@terumo-europe.com

Florence Chow

CONTACT

+32 163 81 645; florence.chow@terumo-europe.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 22, 2023
• Study Start: February 27, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); DE (2); FR (3); BE (2)