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Role of DEB-TACE Versus c-TACE in Treatment of HCC

NCT05093920 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-12

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is listed as the sixth most common cancer worldwide and the third most frequent cause of cancer-related mortality. The majority of HCC cases occurs stem from chronic liver disease and cirrhosis.

Hepatocellular carcinoma accounts for approximately 70% to 90% of all primary liver cancers. Trans-arterial Chemoembolization is the most widely utilized and is considered the first-line treatment recommended for patients staged as intermediate HCC (Barcelona Clinic Liver Cancer stage B). If applied correctly, TACE can produce survival benefits without adversely affecting hepatic functional reserve.

Two TACE techniques have been used since 2004, conventional TACE (c-TACE) and TACE with drug-eluting beads (DEB-TACE). Conventional TACE was evidenced first to treat intermediate stage HCC patients.

Conditions

Interventions

DRUG

Doxorubicin-Eluting Beads

* The patients will be categorized in two randomized groups; c-TACE group (A) and DEB-TACE group (B). * After patient counseling and obtaining a written consent to participate in the study, both groups will be subjected to the interventional procedure according to patient group; Group A; Lipidol-Doxorubicin emulsion material followed by gel foam embolic material will be injected through the catheter directly into tumor feeding vessels through transarterial catheter. Group B; Doxorubicin-Eluting Beads will be injected through the catheter directly into tumor feeding vessels through transarterial catheter.

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Ahmed E Mohamed, Master · Sohag University

  • Mohamed Z Ali, MD · Sohag University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-12-01
Completion
2024-01-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05093920 on ClinicalTrials.gov