Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC
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
1 other identifier
observational
131
1 country
1
Brief 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 of non resectable hepatocellular carcinoma (HCC). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedResults Posted
Study results publicly available
March 30, 2021
CompletedMarch 30, 2021
March 1, 2021
3.8 years
January 28, 2016
February 10, 2020
March 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
30 days
Secondary Outcomes (2)
Tumor Response
6 months, 1 year, 2 year
OS
2 years
Study Arms (1)
Patients with non resectable HCC
DEB-TACE with doxorubicin eluting 100 µ microspheres
Interventions
Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin.
Eligibility Criteria
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.
You may qualify if:
- 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).
- 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.
You may not qualify if:
- ECOG ≥ 1
- Child-Pugh ≥B8.
- Presence of ascitis or encephalopathy
- Extrahepatic tumoral disease.
- Tumoral vascular invasion
- Serum bilirubin\>3 mg/dl.
- 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 %
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Ramón y Cajal
Madrid, 28034, Spain
Related Publications (1)
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.
PMID: 32278280DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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
Results Point of Contact
- Title
- Jose Urbano Garcia, MD, PhD, EBIR, FCIRSE
- Organization
- Ramon y Cajal University Hospital. Vascular and Interventional Radiology Service
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Urbano, MD, PhD,EBIR
HRyC
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, EBIR
Study Record Dates
First Submitted
January 28, 2016
First Posted
February 1, 2016
Study Start
March 1, 2015
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
March 30, 2021
Results First Posted
March 30, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share