Trial Title:
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
NCT ID:
NCT05911633
Condition:
Hepatocellular Carcinoma Non-resectable
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma Non-resectable
HCC
TACE
Chemoembolization
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
BioPearl™
Description:
TACE
Arm group label:
Single arm
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CUB Hôpital Erasme
Address:
City:
Brussels
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Ana-Maria Bucalãu, MD
Email:
maria.bucalau@hubruxelles.be
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Geert Maleux, MD
Phone:
0032 16 34 75 78
Email:
geert.maleux@uzleuven.be
Facility:
Name:
Beaujon Hospital
Address:
City:
Clichy
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Maxime Ronot, MD
Email:
maxime.ronot@aphp.fr
Facility:
Name:
CHU Grenobles (Hôpital Michallon)
Address:
City:
La Tronche
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Julien Ghelfi, MD
Email:
jghelfi@chu-grenoble.fr
Facility:
Name:
Paul-Brousse Hospital
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Clara Prud'homme, MD
Email:
clara.prudhomme@aphp.fr
Facility:
Name:
SLK-Kliniken Heilbronn
Address:
City:
Heilbronn
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Philippe Pereira, MD
Phone:
07131 49-466-63
Email:
Philippe.Pereira@slk-kliniken.de
Facility:
Name:
University Hospital Tübingen
Address:
City:
Tübingen
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Gerd Grözinger, MD
Email:
Gerd.Groezinger@med.uni-tuebingen.de
Facility:
Name:
Fondazione IRCCS Instituto Tumori
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carlo Spreafico, MD
Phone:
39 02 23901
Email:
Carlo.Spreafico@istitutotumori.mi.it
Facility:
Name:
Fondazione Policlinico Universitario A. Gemelli
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Roberto Iezzi, MD
Email:
roberto.iezzi@policlinicogemelli.it
Facility:
Name:
Città della Salute e della Scienza di Torino
Address:
City:
Turin
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paolo Fonio, MD
Email:
paolo.fonio@unito.it
Start date:
February 27, 2024
Completion date:
November 30, 2027
Lead sponsor:
Agency:
Terumo Europe N.V.
Agency class:
Industry
Source:
Terumo Europe N.V.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911633
