Hepatocellular CarcinomaNCT02670122

Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC

An observational study of Hepatocellular Carcinoma, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an observational, multicenter, single arm, prospective study to evaluate safety and tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to 150 mg of doxorubicin, for the treatment… Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Hepatocellular Carcinoma
What is being tested?: DEB-TACE
Type of treatment: Medical device
How many people: 131 participants
Where: 1 siteSpain
Study dates: Mar 2015to 30 Nov 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Target population includes: * Patients with stage B HCC carcinoma according to Barcelona Clinic Liver Cancer classification (BCLC). * Patients with stage A HCC according to BCLC if they are not candidates or not willing to go through surgery or radiofrecuency.

Who may be able to join

Patients with a diagnosis of HCC according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD) criteria and staged by BCLC criteria
Indication for receiving transarterial chemoembolization DEB-TACE with 100 µ microspheres according to usual clinical practice.
Able and willing to participate and give their written informed consent.
Both genders and ≥ 18 years old.
Eastern Cooperative Oncology Group (ECOG) 0
Preserved hepatic function (Child-Pugh ≤ B7).

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No evidence of tumoral invasion in portal vein or main biliary ducts.
Able to go through image diagnostic techniques such as CT or MRI.
Preserved cardiac and renal function.
No concomitant active infections that require antibiotic treatment.
Measurable disease according to mRECIST criteria.
Life expectancy over 6 months.

Who cannot join

ECOG ≥ 1
Child-Pugh ≥B8.
Presence of ascitis or encephalopathy
Extrahepatic tumoral disease.
Tumoral vascular invasion
Serum bilirubin>3 mg/dl.

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Cr Clearance ≤ 60 ml/min
If any of the following is contraindicated:
Administration of doxorubicin
Iodated contrasts
CT or MRI procedures
Transarterial embolization procedures
White blood cells (WBC) < 2000 /mm3
Neutrophil count < 1500 /mm3
Ejection fraction < 50 %
Platelet count < 5 x 104/mm3, international normalized ratio (INR) > 2,0)
Transaminases (AST and/or ALT) > 5x upper limit of normal or >250 u/l
Known hepatofugal portal vein flow
A-V intrahepatic macroscopic fistula
Pregnant or breast feeding women.
Tumor burden involving more than 50% of the liver.
Active bacterial or fungal infection.
Other concomitant tumors.
Any other condition that according to investigator criteria, contraindicates DEB-TACE.
Patients not willing to participate and/or give their written informed consent.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Ramón y Cajal
Madrid, 28034

Other trials in Spain

About this study

Official title: Prospective, Multicenter, Non Randomized, Single Arm Study to Evaluate Safety of Transarterial Chemoembolization (TACE) With Doxorubicin Eluting 100 µ Microspheres in Patients With Non Resectable Hepatocellular Carcinoma

The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads with larger volumes without increasing the risk and complications of DEB-TACE.

Read the detailed description

In this observational, prospective study patients will undergo DEB-TACE and subsequent follow up procedures according to standard clinical practice. The primary aim of the study is to describe treatment safety and tolerability of 100 µ beads in DEB-TACE. As a secondary end-point a description of efficacy parameters will be obtained.

Conditions: Hepatocellular Carcinoma
Being tested: DEB-TACE
Keywords: Hepatocellular Carcinoma, TACE
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DEB-TACEDevice
Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin.

Study groups in NCT02670122
Study group	Role	What they receive
Patients with non resectable HCC		DEB-TACE with doxorubicin eluting 100 µ microspheres Receives: Device: DEB-TACE

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability
Major and minor complications, procedure related mortality and post-embolisation syndrome after DEB-TACE of non-resectable HCC, using 100-µm doxorubicin-loaded microspheres
Measured: 30 days

Secondary outcomes (2)

Tumor Response
Devascularization pattern in the treated tumor, assessed with the modified RECIST (mRECIST), in the contrast enhanced liver CT or MR obtained during FU.
Measured: 6 months, 1 year, 2 year
OS
Overall survival
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201530 Nov 2018

First posted1 Feb 2016 (estimated)
Study startMar 2015
Primary completion30 Nov 2018
Study completion30 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02670122
Sponsor's protocol ID: FJD-TAN-14-01
Status last verified: Mar 2021
First submitted: 28 Jan 2016
Last updated: 30 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Urbano J, Echevarria-Uraga JJ, Ciampi-Dopazo JJ, Sanchez-Corral JA, Cobos Alonso J, Anton-Ladislao A, Pena-Baranda B, Nacarino-Mejias V, Gonzalez-Costero R, Munoz Ruiz-Canela JJ, Perez-Cuesta J, Lanciego C, de Gregorio MA. Multicentre prospective study of drug-eluting bead chemoembolisation safety using tightly calibrated small microspheres in non-resectable hepatocellular carcinoma. Eur J Radiol. 2020 May;126:108966. doi: 10.1016/j.ejrad.2020.108966. Epub 2020 Mar 19.
PubMed 32278280

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Non Randomized, Single Arm Study to Evaluate Safety of Transarterial Chemoembolization (TACE) With Doxorubicin Eluting 100 µ Microspheres in Patients With Non Resectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT02670122
Acronym / sponsor ID: FJD-TAN-14-01
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma, TACE
Study type: Observational
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
Study start: Mar 2015 (actual)
Primary completion: 30 Nov 2018 (actual)
Study completion: 30 Nov 2018 (actual)
First posted: 1 Feb 2016 (estimated)
Results: Posted 30 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads with larger volumes without increasing the risk and complications of DEB-TACE.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with non resectable HCC	–	Device: DEB-TACEDEB-TACE with doxorubicin eluting 100 µ microspheres

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Target population includes: * Patients with stage B HCC carcinoma according to Barcelona Clinic Liver Cancer classification (BCLC). * Patients with stage A HCC according to BCLC if they are not candidates or not willing to go through surgery or radiofrecuency.

Key inclusion criteria (12 listed)

Patients with a diagnosis of HCC according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD) criteria and staged by BCLC criteria
Indication for receiving transarterial chemoembolization DEB-TACE with 100 µ microspheres according to usual clinical practice.
Able and willing to participate and give their written informed consent.
Both genders and ≥ 18 years old.
Eastern Cooperative Oncology Group (ECOG) 0

Key exclusion criteria (25 listed)

ECOG ≥ 1
Child-Pugh ≥B8.
Presence of ascitis or encephalopathy
Extrahepatic tumoral disease.
Tumoral vascular invasion

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
DEB-TACESelective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin.	Device	Patients with non resectable HCC

Primary outcome

Safety and Tolerability
Time frame: 30 days
Major and minor complications, procedure related mortality and post-embolisation syndrome after DEB-TACE of non-resectable HCC, using 100-µm doxorubicin-loaded microspheres

2 secondary outcomes

Tumor Response
Time frame: 6 months, 1 year, 2 year
OS
Time frame: 2 years

Results and safety

Results posted to the registry on 30 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Non Resectable HCC	131	127

Primary outcome: Safety and Tolerability

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Major Complications n = 131	Minor Complications n = 131	Procedure Related Mortality n = 131	Severe PES n = 131
Value	9	29	0	12

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adverse Events	9 of 131 (6.9%)	29 of 131 (22.1%)	48 of 131

Limitations and caveats (from the sponsor): 1. Lack of a comparative arm using larger or smaller DEBs or a cTACE group. 2. Intratumor doxorubicin doses were calculated according to the mL of injected mirospheres

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32278280Urbano J, Echevarria-Uraga JJ, Ciampi-Dopazo JJ, Sanchez-Corral JA, Cobos Alonso J, Anton-Ladislao A, Pena-Baranda B, Nacarino-Mejias V, Gonzalez-Costero R, Munoz Ruiz-Canela JJ, Perez-Cuesta J, Lanciego C, de Gregorio MA. Multicentre prospective study of drug-eluting bead chemoembolisation safety using tightly calibrated small microspheres in non-resectable hepatocellular carcinoma. Eur J Radiol. 2020 May;126:108966. doi: 10.1016/j.ejrad.2020.108966. Epub 2020 Mar 19.
Individual participant dataSharing planned: No

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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.

Jose Urbano, MD, PhD,EBIR principal investigator

HRyC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.

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 12 inclusion and 25 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety and Tolerability (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02670122, which also lists 1 linked publication.

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 30 Mar 2021.