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Trial record 1 of 1 for:    jose urbano garcia
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Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC

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ClinicalTrials.gov Identifier: NCT02670122
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Jose Urbano Garcia, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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.


Condition or disease Intervention/treatment
Hepatocellular Carcinoma Device: DEB-TACE

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.

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Group/Cohort Intervention/treatment
Patients with non resectable HCC
DEB-TACE with doxorubicin eluting 100 µ microspheres
Device: DEB-TACE
Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin.




Primary Outcome Measures :
  1. Procedure related adverse reactions and 30 days mortality [ Time Frame: 30 days, 6 months, 1 year, 2 year ]
    Incidence of major and minor complications related to the procedure and 30 days mortality


Secondary Outcome Measures :
  1. Tumor response [ Time Frame: 3 months, 1 year, 2 year ]
    Devascularization pattern assessed with modified RECIST (mRECIST)

  2. Post embolization syndrome [ Time Frame: 1 week ]
    Incidence of post embolization syndrome 1 week after the procedure

  3. Progression Free Survival (PFS) [ Time Frame: 2 years ]
    Progression free survival

  4. Time to progression (TTP) [ Time Frame: 2 years ]
    Time to untreatable TACE progression

  5. Overall survival [ Time Frame: 2 years ]
    Overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. 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
  2. Indication for receiving transarterial chemoembolization DEB-TACE with 100 µ microspheres according to usual clinical practice.
  3. Able and willing to participate and give their written informed consent.
  4. Both genders and ≥ 18 years old.
  5. Eastern Cooperative Oncology Group (ECOG) 0
  6. Preserved hepatic function (Child-Pugh ≤ B7).
  7. No evidence of tumoral invasion in portal vein or main biliary ducts.
  8. Able to go through image diagnostic techniques such as CT or MRI.
  9. Preserved cardiac and renal function.
  10. No concomitant active infections that require antibiotic treatment.
  11. Measurable disease according to mRECIST criteria.
  12. Life expectancy over 6 months.

Exclusion Criteria:

  1. ECOG ≥ 1
  2. Child-Pugh ≥B8.
  3. Presence of ascitis or encephalopathy
  4. Extrahepatic tumoral disease.
  5. Tumoral vascular invasion
  6. Serum bilirubin>3 mg/dl.
  7. Cr Clearance ≤ 60 ml/min
  8. If any of the following is contraindicated:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670122


Locations
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Spain
Fundación Jiménez Díaz
Madrid, Spain, 28040
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Investigators
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Principal Investigator: Jose Urbano, MD, PhD,EBIR FJD
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Responsible Party: Jose Urbano Garcia, MD, PhD, EBIR, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT02670122    
Other Study ID Numbers: FJD-TAN-14-01
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jose Urbano Garcia, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz:
Hepatocellular Carcinoma
TACE
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases