Hepatocellular CarcinomaBIOPEARL-FIRSTNCT04231929
BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
A study testing Chemoembolization in people with Hepatocellular Carcinoma, run by Terumo Europe N.V. at 3 sites in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Chemoembolization
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesBelgium
- Study dates
- May 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years old.
- Patient with HCC confirmed by histology or according to the latest applicable version of the EASL criteria.
- 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.
- 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.
- Patient deemed treatable in one session for initial treatment.
- Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A).
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- Total bilirubin ≤ 2.0 mg/dl.
- Patient with no ascites or with medically controlled ascites.
- Adequate renal function (serum creatinine < 1.5 X ULN).
- Patient has provided written informed consent.
Who cannot join
- Patient previously treated with any systemic therapy for HCC.
- Patient previously treated with a loco-regional therapy for HCC. Prior resection/ablation is allowed as per inclusion criteria 4.
- Eligible for curative treatment at the time of study inclusion.
- 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).
- Patient with another primary tumor.
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- Patient 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.
- 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.
- 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.
- Pregnant or breast-feeding women.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
CUB Hôpital Erasme
Brussels, 1070
UZ Gent
Ghent, 9000
University Hospital Leuven
Leuven, 3000
About this study
Official title: BioPearl™ Microspheres Loaded With Doxorubicin to Treat Patients With Unresectable HCC: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
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).
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Chemoembolization
- Keywords
- HCC, Unresectable, BioPearl®, TACE, Chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoembolizationDevice
Also called TACE
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.
| Study group | Role | What they receive |
|---|---|---|
| BioPearl™ loaded with doxorubicin | Experimental | Chemoembolization with doxorubicin-loaded BioPearl™ microspheres Receives: Device: Chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3-4-5 adverse events related with procedure or study device
Safety by monitoring and evaluating all grade 3-4-5 adverse events related with procedure or study device
Measured: 4 weeks
Tumor response
Tumor response rate assessed by mRECIST criteria
Measured: 4 weeks
Tumor response
Tumor response rate assessed by mRECIST criteria
Measured: 12 weeks
Secondary outcomes (7)
Technical success
Ability to reach stasis in the treated tumor feeding arteries during chemoembolization procedure
Measured: 1 day
Time to progression of treated tumor(s)
Time from treatment to progression of the treated lesion according to mRECIST criteria
Measured: 3 years
Time to un-TACEable progression
Time from treatment to un-TACEable progression of the treated lesion according to EASL criteria
Measured: 3 years
Hepatic progression free survival
Time from treatment to progression anywhere in the liver according to mRECIST criteria or death from any cause
Measured: 3 years
Progression free survival
Time from treatment to progression in the liver or outside the liver or death from any cause
Measured: 3 years
Overall survival
Time from treatment until death from any cause
Measured: 3 years
Best overall response
Best response of treated tumor(s) recorded during the course of the study according to mRECIST criteria
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startMay 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study cancelled by Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gontran Verset, MD, Principal investigator, CUB Hôpital ErasmeGeert Maleux, MD, Principal investigator, UZ LeuvenLuc Defreyne, MD, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231929
- Sponsor's protocol ID
- T135E5
- Acronym
- BIOPEARL-FIRST
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2020
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioPearl™ Microspheres Loaded With Doxorubicin to Treat Patients With Unresectable HCC: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
- ClinicalTrials.gov ID
- NCT04231929
- Acronym / sponsor ID
- BIOPEARL-FIRST / T135E5
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, Unresectable, BioPearl®, TACE, Chemoembolization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled by Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- May 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioPearl™ loaded with doxorubicin | Experimental | Device: ChemoembolizationChemoembolization with doxorubicin-loaded BioPearl™ microspheres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is at least 18 years old.
- Patient with HCC confirmed by histology or according to the latest applicable version of the EASL criteria.
- 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.
- 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.
- Patient deemed treatable in one session for initial treatment.
Key exclusion criteria (14 listed)
- Patient previously treated with any systemic therapy for HCC.
- Patient previously treated with a loco-regional therapy for HCC. Prior resection/ablation is allowed as per inclusion criteria 4.
- Eligible for curative treatment at the time of study inclusion.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoembolizationAlso: TACEFirst, 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. | Device | BioPearl™ loaded with doxorubicin |
Primary outcome
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
Tumor response
Time frame: 4 weeks
Tumor response rate assessed by mRECIST criteria
Tumor response
Time frame: 12 weeks
Tumor response rate assessed by mRECIST criteria
7 secondary outcomes
Technical success
Time frame: 1 day
Time to progression of treated tumor(s)
Time frame: 3 years
Time to un-TACEable progression
Time frame: 3 years
Hepatic progression free survival
Time frame: 3 years
Progression free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Best overall response
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gontran Verset, MD principal investigator
CUB Hôpital Erasme
Geert Maleux, MD principal investigator
UZ Leuven
Luc Defreyne, MD principal investigator
UZ Gent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemoembolization in people with Hepatocellular Carcinoma, run by Terumo Europe N.V. at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3-4-5 adverse events related with procedure or study device (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.