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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: HepatoCellular Carcinoma

Treatments: Drug: Trans-arterial chemoembolization (TACE); Drug: TACE with Drug Eluting Beads procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03007225

treatment of HCC

Details and patient eligibility

About

This study aimed to to compare the conventional transarterial chemoembolization (cTACE) with chemoembolization using doxorubicin drug eluting beads (DEB-TACE) for the treatment of hepatocellular carcinoma regarding short term efficacy and safety in first 3 months after embolization

Full description

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.

Enrollment: 50 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• patients refused to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

group 1 Drug eluting beads intervention

Active Comparator group

Description:

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

Treatment:

Drug: TACE with Drug Eluting Beads procedure

group 2 Conventional TACE intervention

Active Comparator group

Description:

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

Treatment:

Drug: Trans-arterial chemoembolization (TACE)