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

NCT ID: NCT05911633

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2027-12-30

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.

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.

Conditions

Hepatocellular Carcinoma Non-resectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: OTHER

BioPearl™

Intervention Type: DEVICE

TACE

Interventions

BioPearl™

TACE

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is at least 18 years old

2. 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

3. 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

4. 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

5. 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

6. WHO (World Health Organization) or ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1

7. Subject deemed treatable in one session for initial treatment

8. Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A)

9. Total bilirubin ≤ 2.0 mg/dl

10. Adequate bone marrow function: Hemoglobin ≥ 9g/dl, absolute neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L

11. Subject with no ascites or with minor ascites controlled by sodium dietary restrictions (subject receiving diuretic treatment or paracentesis is not eligible)

12. Adequate renal function: serum creatinine < 1.5 X ULN (Upper Limit of Normal)

13. Subject has provided written informed consent

14. Subjects of childbearing/reproductive potential should use adequate birth control measures, during the study treatment period until survival follow-up

Exclusion Criteria

1. Subject previously treated with any systemic therapy for HCC

2. Subject previously treated with intra-arterial loco-regional therapy for HCC

3. Eligible for curative treatment at the time of study inclusion

4. Recurrence in the segment of a prior thermal ablation

5. Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy

6. Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status >1)

7. History of another primary tumor. Exceptions include:

A. Malignancy treated with curative intent ≥ 5 years before inclusion and with no known active disease

B. Malignancy which occurred < 5 years before, not active and not expected to recur or be clinically relevant in the next 5 years

8. Subject with history of biliary tree disease or biliary dilatation

9. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated

10. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media)

11. Any other contraindication for embolization procedure or Doxorubicin treatment

12. 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

13. 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

14. Pregnant or breast-feeding woman

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Europe N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Pierre Dewez

Role: STUDY_DIRECTOR

Terumo Europe EMCD

Locations

CUB Hôpital Erasme

Brussels, , Belgium

Site Status: RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

Beaujon Hospital

Clichy, , France

Site Status: RECRUITING

CHU Grenobles (Hôpital Michallon)

La Tronche, , France

Site Status: NOT_YET_RECRUITING

Paul-Brousse Hospital

Villejuif, , France

Site Status: RECRUITING

SLK-Kliniken Heilbronn

Heilbronn, , Germany

Site Status: RECRUITING

University Hospital Tübingen

Tübingen, , Germany

Site Status: RECRUITING

Fondazione IRCCS Instituto Tumori

Milan, , Italy

Site Status: RECRUITING

Fondazione Policlinico Universitario A. Gemelli

Rome, , Italy

Site Status: RECRUITING

Città della Salute e della Scienza di Torino

Turin, , Italy

Site Status: RECRUITING

Countries

Belgium; France; Germany; Italy

Central Contacts

Tamara Sals

Role: CONTACT

tamara.sals@terumo-europe.com

+32 483 53 41 06

Florence Chow

Role: CONTACT

florence.chow@terumo-europe.com

+32 163 81 645

Facility Contacts

Ana-Maria Bucalãu, MD

Role: primary

maria.bucalau@hubruxelles.be

Geert Maleux, MD

Role: primary

geert.maleux@uzleuven.be

0032 16 34 75 78

Maxime Ronot, MD

Role: primary

maxime.ronot@aphp.fr

Julien Ghelfi, MD

Role: primary

jghelfi@chu-grenoble.fr

Clara Prud'homme, MD

Role: primary

clara.prudhomme@aphp.fr

Gerd Grözinger, MD

Role: primary

gerd.groezinger@slk-kliniken.de

Jörg Schmehl, MD

Role: primary

Joerg.Schmehl@med.uni-tuebingen.de

Tommaso Cascella, MD

Role: primary

Tommaso.Cascella@istitutotumori.mi.it

Roberto Iezzi, MD

Role: primary

roberto.iezzi@policlinicogemelli.it

Paolo Fonio, MD

Role: primary

paolo.fonio@unito.it

References

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.

Reference Type: DERIVED

PMID: 39972606 (View on PubMed)

Other Identifiers

T144E3

Identifier Type: -

Identifier Source: org_study_id