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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670122
• Other study ID #: FJD-TAN-14-01
• Status: Completed
• Start date: March 2015
• Est. completion date: November 30, 2018

Study information

• Verified date: March 2021
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Major and minor complications, procedure related mortality and post-embolisation syndrome after DEB-TACE of non-resectable HCC, using 100-µm doxorubicin-loaded microspheres	30 days
Secondary	Tumor Response	Devascularization pattern in the treated tumor, assessed with the modified RECIST (mRECIST), in the contrast enhanced liver CT or MR obtained during FU.	6 months, 1 year, 2 year
Secondary	OS	Overall survival	2 years