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

Phase 4

Completed

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

Brief Summary: 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

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
group 1 Drug eluting beads intervention	TACE with Drug Eluting Beads procedure	Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg)
group 2 Conventional TACE intervention	Trans-arterial chemoembolization (TACE)	Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Response	1 year	Assessment of Radiological response by modified RECIST radiological criteria after treatment (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.")

Secondary Outcome Measures