Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC
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|ClinicalTrials.gov Identifier: NCT02670122|
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : February 27, 2019
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.
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma||Device: DEB-TACE|
|Study Type :||Observational|
|Actual Enrollment :||130 participants|
|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|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||November 30, 2018|
Patients with non resectable HCC
DEB-TACE with doxorubicin eluting 100 µ microspheres
Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin.
- Procedure related adverse reactions and 30 days mortality [ Time Frame: 30 days, 6 months, 1 year, 2 year ]Incidence of major and minor complications related to the procedure and 30 days mortality
- Tumor response [ Time Frame: 3 months, 1 year, 2 year ]Devascularization pattern assessed with modified RECIST (mRECIST)
- Post embolization syndrome [ Time Frame: 1 week ]Incidence of post embolization syndrome 1 week after the procedure
- Progression Free Survival (PFS) [ Time Frame: 2 years ]Progression free survival
- Time to progression (TTP) [ Time Frame: 2 years ]Time to untreatable TACE progression
- Overall survival [ Time Frame: 2 years ]Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670122
|Fundación Jiménez Díaz|
|Madrid, Spain, 28040|
|Principal Investigator:||Jose Urbano, MD, PhD,EBIR||FJD|