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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Observational Prospective Study on Chemoembolization With Doxorubicin for Unresectable Hepatocellular Carcinoma

NCT01891539

Liver Cell Carcinoma Non-resectable

UNKNOWN

Safety and Efficacy of DEB-TACE Performed With a Novel Reflux-control Microcatheter in Patients With HCC

NCT04653701

Hepatocellular Carcinoma Liver Cancer

UNKNOWN

TACE Using Doxorubicin-eluting Beads for Patients With HCC and Marginal Hepatic Reserve

NCT02147301

Hepatocellular Carcinoma Chemoembolization

TERMINATED NA

DEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCC

NCT04967482

Hepatocellular Carcinoma Non-resectable

UNKNOWN NA

DEB-TACE for Hepatocellular Carcinoma

NCT02748161

Hepatocellular Carcinoma

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with non resectable HCC

DEB-TACE with doxorubicin eluting 100 µ microspheres

DEB-TACE

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No