N/A Completed N=131

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

Hepatocellular Carcinoma

Source: ClinicalTrials.gov NCT02670122 ↗

Enrolled (actual)

131

Serious AEs

6.9%

Results posted

Mar 2021

Primary outcomePrimary: Safety and Tolerability — 9; 29; 0; 12 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Tolerability	9; 29; 0; 12	—
SECONDARY Tumor Response	90; 42; 27	—
SECONDARY OS	22	—

Eligibility Criteria

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:
Administration of doxorubicin
Iodated contrasts
CT or MRI procedures
Transarterial embolization procedures
White blood cells (WBC) 2,0)
Transaminases (AST and/or ALT) > 5x upper limit of normal or >250 u/l
Known hepatofugal portal vein flow
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02670122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.