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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
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.
Investigators
Jose Urbano Garcia
MD, PhD, EBIR
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Eligibility Criteria
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.
Exclusion Criteria
- •Child-Pugh ≥B
- •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
Outcomes
Primary Outcomes
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
- Tumor Response(6 months, 1 year, 2 year)
- OS(2 years)