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BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study. (BIOPEARL-FIRST)

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ClinicalTrials.gov Identifier: NCT04231929
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.

Brief Summary:
The primary objective of the study is to confirm safety and efficacy of BioPearl™ microspheres loaded with doxorubicin in the treatment of patients with unresectable hepatocellular carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Device: Chemoembolization Not Applicable

Detailed Description:

This is a prospective, single arm, multi-centre, post-market study to further assess safety and efficacy in 20 unresectable HCC patients treated with Doxorubicin loaded BioPearl™ microspheres.

After the treatment procedure, all patients will undergo clinical follow-up until disease progression and/or next treatment option after which patients will be followed for survival. Patients will be followed up to a maximum of 3 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: BioPearl™ Microspheres Loaded With Doxorubicin to Treat Patients With Unresectable HCC: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BioPearl™ loaded with doxorubicin
Chemoembolization with doxorubicin-loaded BioPearl™ microspheres
Device: Chemoembolization

First, an angiography of the celiac trunk, superior mesenteric artery and hepatic artery will be obtained by using a peripheral arterial approach.

Arterial embolization will be performed through catheterization of intrahepatic arteries, as selectively as possible (tumor feeders, subsegmental, segmental). The size of the microcatheter must be consistent with the size of BioPearl™ microspheres used. Microspheres of 200 µm will be be used. They will be loaded with the appropriate dose of doxorubicin injectable solution, mixed with the contrast media and distributed according to the location of the HCC lesions. The endpoint of the procedure will be achieved end when stasis of the feeders is achieved.

Other Name: TACE




Primary Outcome Measures :
  1. Incidence of grade 3-4-5 adverse events related with procedure or study device [ Time Frame: 4 weeks ]
    Safety by monitoring and evaluating all grade 3-4-5 adverse events related with procedure or study device

  2. Tumor response [ Time Frame: 4 weeks ]
    Tumor response rate assessed by mRECIST criteria

  3. Tumor response [ Time Frame: 12 weeks ]
    Tumor response rate assessed by mRECIST criteria


Secondary Outcome Measures :
  1. Technical success [ Time Frame: 1 day ]
    Ability to reach stasis in the treated tumor feeding arteries during chemoembolization procedure

  2. Time to progression of treated tumor(s) [ Time Frame: 3 years ]
    Time from treatment to progression of the treated lesion according to mRECIST criteria

  3. Time to un-TACEable progression [ Time Frame: 3 years ]
    Time from treatment to un-TACEable progression of the treated lesion according to EASL criteria

  4. Hepatic progression free survival [ Time Frame: 3 years ]
    Time from treatment to progression anywhere in the liver according to mRECIST criteria or death from any cause

  5. Progression free survival [ Time Frame: 3 years ]
    Time from treatment to progression in the liver or outside the liver or death from any cause

  6. Overall survival [ Time Frame: 3 years ]
    Time from treatment until death from any cause

  7. Best overall response [ Time Frame: 3 years ]
    Best response of treated tumor(s) recorded during the course of the study according to mRECIST criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is at least 18 years old.
  2. Patient with HCC confirmed by histology or according to the latest applicable version of the EASL criteria.
  3. Patient with a single nodular tumor 6 cm or less in longest diameter or patient with no more than three tumor nodules, each 4 cm or less in longest diameter. Infiltrative disease is excluded.
  4. BCLC B patient or BCLC A patient not a candidate for curative treatment at the time of study inclusion or who has failed/recurred after resection/ablation.
  5. Patient deemed treatable in one session for initial treatment.
  6. Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A).
  7. Total bilirubin ≤ 2.0 mg/dl.
  8. Patient with no ascites or with medically controlled ascites.
  9. Adequate renal function (serum creatinine < 1.5 X ULN).
  10. Patient has provided written informed consent.

Exclusion Criteria:

  1. Patient previously treated with any systemic therapy for HCC.
  2. Patient previously treated with a loco-regional therapy for HCC. Prior resection/ablation is allowed as per inclusion criteria 4.
  3. Eligible for curative treatment at the time of study inclusion.
  4. Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy.
  5. Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status ≥1).
  6. Patient with another primary tumor.
  7. Patient with history of biliary tree disease or biliary dilatation.
  8. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated.
  9. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media).
  10. Any other contraindication for embolization procedure or doxorubicin treatment.
  11. Patient 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.

  12. In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
  13. Pregnant or breast-feeding women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231929


Contacts
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Contact: Florence Chow +3216 38 12 11 florence.chow@terumo-europe.com
Contact: Jan D'haeyer, MD +3216 38 12 11 Jan.Dhaeyer@terumo-europe.com

Locations
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Belgium
CUB Hôpital Erasme
Brussels, Belgium, 1070
Contact: Gontran Verset, MD         
UZ Gent
Gent, Belgium, 9000
Contact: Luc Defreyne, MD         
University Hospital Leuven
Leuven, Belgium, 3000
Contact: Geert Maleux, MD         
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
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Principal Investigator: Gontran Verset, MD CUB Hôpital Erasme
Principal Investigator: Geert Maleux, MD UZ Leuven
Principal Investigator: Luc Defreyne, MD UZ Gent
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Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT04231929    
Other Study ID Numbers: T135E5
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terumo Europe N.V.:
HCC
Unresectable
BioPearl®
TACE
Chemoembolization
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases