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

Completed

Lead Sponsor: 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.

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.

Recruitment & Eligibility

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:
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
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.

Arm && Interventions

Group	Intervention	Description
Patients with non resectable HCC	DEB-TACE	DEB-TACE with doxorubicin eluting 100 µ microspheres

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	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 Outcome Measures

Name	Time	Method
Tumor Response	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.
OS	2 years	Overall survival