Completed

Efficacy and Safety of Drug Eluting Beads TACE in Treatment of HCC in Egyptian Patients

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What is being tested

Trans-arterial chemoembolization (TACE)

+ TACE with Drug Eluting Beads procedure

Drug
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2015
See protocol details

Summary

Principal SponsorAin Shams University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2015

Actual date on which the first participant was enrolled.

This prospective case control was conducted at the Department of Tropical Medicine and HCC Clinic, Ain Shams University Hospitals (Cairo, Egypt), The patients were divided according to the line of treatment into 2 groups: 1. Group (I): Twenty-five patients underwent Chemoembolization with Drug eluting beads. 2. Group (II): Twenty-five patients underwent conventional Chemoembolization (cTACE) The total number of procedures was 77 sessions (37 sessions of TACE with beads and 40 sessions of conventional TACE).Post-procedure follow up: Schedule of follow up: All included patients were checked at: 1. One week after the procedure to detect early post chemoembolization complications and Patients were subjected to Liver function tests, Kidney function tests, complete blood count and Abdominal Ultrasound. 2. One and four months after the maneuver. Patients were subjected to the following in each visit: 1. Complete History taking 2. Thorough clinical examination 3. Laboratory Investigations including: 1. Liver function tests 2. Kidney function tests 3. CBC 4. Serum alpha-fetoprotein. 4. Triphasic pelvi-abdominal CT Follow up imaging was performed at the first and fourth months after embolization and every 3 months thereafter. Repeated embolization was scheduled "on demand" basis, if there was residual viable tumor deemed unsuitable for radiofrequency ablation or surgery.

Official TitleEfficacy and Safety of Drug Eluting Beads TACE in Treatment of HCC in Egyptian Patients
NCT03007225
Principal SponsorAin Shams University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial

Criteria

4 inclusion criteria required to participate
Confirmed diagnosis of HCC according to the European association of study of liver diseases

Early stage HCC (Stage A), using the Barcelona Clinic Liver Cancer (BCLC) staging system, (single or 3 nodules < 3cm PS 0) whenever curative measures were contraindicated and BCLC stage B (intermediate HCC).

Patent portal vein and its main branches

Informed consent from all participants before enrollment in the study.

5 exclusion criteria prevent from participating
Patients with Child class C according to Child classification (BCLC D).

Patients with diffuse HCC (non-measurable lesion).

Patients with thrombosis of main portal vein or one of its main branches (BCLC C).

Patients with extra hepatic invasion.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique

Group II

Active Comparator
Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)

Study Objectives

Primary Objectives

Study Centers

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CompletedNo study centers