HCCNCT02548780
LifePearl-Doxo Pharmacokinetic (PK) Study
A study testing Chemoembolization and Pharmacokinetics in people with HCC and Hepatocellular Carcinoma, run by Terumo Europe N.V. at 3 sites in 3 countries.
Trial summary
The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC, Hepatocellular Carcinoma
- What is being tested?
- Chemoembolization and Pharmacokinetics
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2016to 18 Oct 2019
- 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
- HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) or EASL-European Organization for Research and Treatment of Cancer (EORTC) criteria
- BCLC B patients or BCLC A patients not candidates for curative treatment (resection, transplantation, ablation) or who have failed/recurred after resection/ablation
- Tumor burden (located in one or two lobes) that can be sufficiently and selectively embolized with required dose of LifePearl loaded with doxorubicin
- Performance status (PS) 0
- Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh A, score ≤ 6 points) without ascites in the absence of diuretic treatment
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- Total bilirubin ≤2.0 mg/dl
- Adequate renal function (serum creatinine < 1.5 X ULN)
- Patient has provided written informed consent
- Patient is affiliated to social security or equivalent system (France only)
Who cannot join
- Patient previously treated with any intra-arterial therapy for HCC or sorafenib
- Eligible for curative treatment (resection/radiofrequency ablation (RFA), transplantation therapies);
- Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels >2.0 mg/dl;
- Advanced tumoral disease: BCLC class C (vascular invasion -even segmental, extra-hepatic spread or cancer-related symptoms=PS of 1-2) or D class (WHO performance status 3 or 4)
- Patient with another primary tumor
- Patient with refractory ascites or on diuretic treatment
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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 or local doxorubicine 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
- 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
- Patient is under judicial protection (France only)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Pharmacokinetic Study in Patients With Unresectable Hepatocellular Carcinoma (HCC) Receiving Treatment With LifePearl Microspheres Loaded With Doxorubicin
The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable HCC.
Read the detailed description
This is a multicentre, prospective dose escalation/PK study, designed to assess the clinical performance of LifePearl™ beads loaded with Doxorubicin in the primary treatment of unresectable HCC by chemoembolization. Data from this study will be used as supportive data post CE-mark approval.
The main objective of the study is to evaluate the safety and pharmacokinetic profile of LifePearl™ beads loaded with Doxorubicin in the treatment of patients with unresectable liver cancer (HCC) by chemoembolization. This will be measured as treatment-related complications and plasma levels of Doxorubicin in peripheral blood.
In addition, objective tumour response will be assessed by computed tomography or MRI.
Two cohorts of patients will be evaluated:
Cohort I to assess safety (dose escalation) and pharmacokinetic profile; Cohort II will assess pharmacokinetic profile, safety and efficacy with the doxorubicin dose determined with Cohort I.
- Conditions
- HCC, Hepatocellular Carcinoma
- Being tested
- Chemoembolization, Pharmacokinetics
- Keywords
- unresectable
- 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 Chemoembolization with LifePearl™ loaded with Doxorubicine
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 LifePearl beads 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 and confirmed with angiography of the whole liver.
PharmacokineticsOther
Pharmacokinetic analysis will be performed in cohort I and II after the first treatment only. In addition to blood samples taken for biochemistry and haematology analysis, blood will be taken for pharmacokinetic assessment: Whole venous blood samples (6 ml in 2 tubes) will be taken from peripheral blood into ethylenediaminetetraacetic acid (EDTA) tubes prior to and at 5mins, 20mins, 40mins, 1h, 2h, 6h, 24h, 48h and 7 days after the procedure, and if needed (i.e. value at d7 is detectable) at 1 month (for safety assessment visit) either during hospital stay or in the outpatient clinic.
| Study group | Role | What they receive |
|---|---|---|
| Chemoembolization + Pharmacokinetics | Experimental | First cohort: Chemoembolization with Doxorubicin-loaded LifePearl™ microspheres (TACE): Escalation of dose loaded in microspheres from 75 mg to 150 mg. Pharmacokinetic testing in all patients.
Second cohort: Chemoembolization with doxorubicin-loaded LifePearl™microspheres: microspheres loaded with maximum tolerated dose as established with dose escalation arm. Pharmacokinetic testing in all patients. Receives: Device: Chemoembolization; Other: Pharmacokinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Doxorubicine
Adverse Events (CTCAE v4.03 toxicity criteria) occurring within 28 days of the treatment. Grade ≥4 or Grade 3 in two patients at any one dose will mean the MTD has been achieved.
Measured: 1 month
Peak Plasma Concentration (Cmax)
Maximum Plasma Concentration Doxorubicine
Measured: 1 month
Adverse Events
Occurence of grade 3-4-5 treatment-related adverse events as Assessed by CTCAE v4.0.
Measured: 1 month
Area under the Curve (AUC)
Measured: 1 month
Secondary outcomes (6)
Angiographic Stasis
Ability to achieve stasis of bloodflow in the embolised arteries by angiographic assessment.
Measured: 1 day
Total dose delivered
Sum of all doses Doxorubicine administered (maximum two chemoembolizations)
Measured: 2 months
Response rate
Response rate assessed by Response Evaluation Criteria in Solid Tumors(RECIST) 1.1, EASL (European Association for the Study of the Liver) and mRECIST (modified RECIST) criteria 3 months after the first treatment
Measured: 3 months
Time to Progression
Progression will be defined by the Barcelona Clinic Liver Cancer (BCLC)-refined RECIST
Measured: 24 months
Overall Survival
The length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.
Measured: 24 months
Progression Free Survival
The length of time during and after the treatment that a patient lives with the disease but it does not get worse.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startApr 2016
- Primary completionOct 2018
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federation Francophone de Cancerologie Digestive, Fundacion Clinic per a la Recerca Biomédica
- Responsible party
- Sponsor
- Investigators
- Jordi Bruix, MD, Principal investigator, CLÍNIC BARCELONA Hospital Universitari, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548780
- Sponsor's protocol ID
- T125E2
- Status last verified
- Jan 2020
- First submitted
- 27 Aug 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study in Patients With Unresectable Hepatocellular Carcinoma (HCC) Receiving Treatment With LifePearl Microspheres Loaded With Doxorubicin
- ClinicalTrials.gov ID
- NCT02548780
- Acronym / sponsor ID
- T125E2
- Conditions
- HCC, Hepatocellular Carcinoma
- Keywords
- unresectable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Collaborators
- Federation Francophone de Cancerologie Digestive, Fundacion Clinic per a la Recerca Biomédica
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 14 Sep 2015 (estimated)
- 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 purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable HCC.
Detailed description
This is a multicentre, prospective dose escalation/PK study, designed to assess the clinical performance of LifePearl™ beads loaded with Doxorubicin in the primary treatment of unresectable HCC by chemoembolization. Data from this study will be used as supportive data post CE-mark approval.
The main objective of the study is to evaluate the safety and pharmacokinetic profile of LifePearl™ beads loaded with Doxorubicin in the treatment of patients with unresectable liver cancer (HCC) by chemoembolization. This will be measured as treatment-related complications and plasma levels of Doxorubicin in peripheral blood.
In addition, objective tumour response will be assessed by computed tomography or MRI.
Two cohorts of patients will be evaluated:
Cohort I to assess safety (dose escalation) and pharmacokinetic profile; Cohort II will assess pharmacokinetic profile, safety and efficacy with the doxorubicin dose determined with Cohort I.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoembolization + Pharmacokinetics | Experimental | Device: Chemoembolization, Other: PharmacokineticsFirst cohort: Chemoembolization with Doxorubicin-loaded LifePearl™ microspheres (TACE): Escalation of dose loaded in microspheres from 75 mg to 150 mg. Pharmacokinetic testing in all patients. Second cohort: Chemoembolization with doxorubicin-loaded LifePearl™microspheres: microspheres loaded with maximum tolerated dose as established with dose escalation arm. Pharmacokinetic testing in all patients. |
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
- HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) or EASL-European Organization for Research and Treatment of Cancer (EORTC) criteria
- BCLC B patients or BCLC A patients not candidates for curative treatment (resection, transplantation, ablation) or who have failed/recurred after resection/ablation
- Tumor burden (located in one or two lobes) that can be sufficiently and selectively embolized with required dose of LifePearl loaded with doxorubicin
- Performance status (PS) 0
Key exclusion criteria (14 listed)
- Patient previously treated with any intra-arterial therapy for HCC or sorafenib
- Eligible for curative treatment (resection/radiofrequency ablation (RFA), transplantation therapies);
- Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels >2.0 mg/dl;
- Advanced tumoral disease: BCLC class C (vascular invasion -even segmental, extra-hepatic spread or cancer-related symptoms=PS of 1-2) or D class (WHO performance status 3 or 4)
- Patient with another primary tumor
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: Chemoembolization with LifePearl™ loaded with DoxorubicineFirst, 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 LifePearl beads 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 and confirmed with angiography of the whole liver. | Device | Chemoembolization + Pharmacokinetics |
| PharmacokineticsPharmacokinetic analysis will be performed in cohort I and II after the first treatment only. In addition to blood samples taken for biochemistry and haematology analysis, blood will be taken for pharmacokinetic assessment: Whole venous blood samples (6 ml in 2 tubes) will be taken from peripheral blood into ethylenediaminetetraacetic acid (EDTA) tubes prior to and at 5mins, 20mins, 40mins, 1h, 2h, 6h, 24h, 48h and 7 days after the procedure, and if needed (i.e. value at d7 is detectable) at 1 month (for safety assessment visit) either during hospital stay or in the outpatient clinic. | Other | Chemoembolization + Pharmacokinetics |
Primary outcome
Maximum Tolerated Dose (MTD) of Doxorubicine
Time frame: 1 month
Adverse Events (CTCAE v4.03 toxicity criteria) occurring within 28 days of the treatment. Grade ≥4 or Grade 3 in two patients at any one dose will mean the MTD has been achieved.
Peak Plasma Concentration (Cmax)
Time frame: 1 month
Maximum Plasma Concentration Doxorubicine
Adverse Events
Time frame: 1 month
Occurence of grade 3-4-5 treatment-related adverse events as Assessed by CTCAE v4.0.
Area under the Curve (AUC)
Time frame: 1 month
6 secondary outcomes
Angiographic Stasis
Time frame: 1 day
Total dose delivered
Time frame: 2 months
Response rate
Time frame: 3 months
Time to Progression
Time frame: 24 months
Overall Survival
Time frame: 24 months
Progression Free Survival
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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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.
Jordi Bruix, MD principal investigator
CLÍNIC BARCELONA Hospital Universitari, Spain
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemoembolization and Pharmacokinetics in people with HCC and Hepatocellular Carcinoma, run by Terumo Europe N.V. at 3 sites in 3 countries.
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: finished, as of the sponsor's last update on 27 Jan 2020. 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 Greece, Spain, Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) of Doxorubicine (time frame: 1 month). The study lists 4 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 27 Jan 2020.