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

January 20, 2025 updated by: Terumo Europe N.V.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm
Transarterial Chemo Embolization (TACE) with BioPearl™ microspheres loaded with Doxorubicin
Device: BioPearl™
TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Day 1
Ability to reach near stasis in the treated tumor feeding arteries during chemoembolization procedure
Day 1
Safety: by evaluating all procedural or study device related grade 3-4-5 adverse events (AEs)
Time Frame: Day 29
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response rate
Time Frame: 18 months
Assessed by mRECIST (modified Response Evaluation Criteria in Solid Tumors) criteria at 4 weeks and every 3 months as per local investigator assessment
18 months
Duration of response
Time Frame: 18 months
According to mRECIST as per local investigator assessment
18 months
Progression Free Survival (PFS)
Time Frame: 18 months
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
18 months
Time to progression
Time Frame: 18 months
Defined as time from treatment to progression according to mRECIST criteria as per local investigator assessment
18 months
Best response
Time Frame: 18 months
Defined as best response recorded during the study according to mRECIST criteria as per local investigator assessment
18 months
Survival Rate
Time Frame: 18 months
up to 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terumo Europe N.V.

Investigators

  • Study Director: Marie-Pierre Dewez, Terumo Europe EMCD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T144E3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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