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NCT Number: NCT02670122

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Ramón y Cajal

Madrid, 28034, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 %
  • 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.

Treatment and study plan

DEB-TACE

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Tumor Response

    Time frame: 6 months, 1 year, 2 year

    Devascularization pattern in the treated tumor, assessed with the modified RECIST (mRECIST), in the contrast enhanced liver CT or MR obtained during FU.

  2. OS

    Time frame: 2 years

    Overall survival

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2016
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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