Clinical trial NCT02670122: Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
TACE
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 30 days
Secondary outcomes:
measure: Tumor Response
timeFrame: 6 months, 1 year, 2 year
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: HRyC
name: Jose Urbano, MD, PhD,EBIR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.