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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03007225
Enrollment
50
Registered
2017-01-02
Start date
2015-07-31
Completion date
2016-08-31
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HepatoCellular Carcinoma

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.

Interventions

TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography of the Coeliac and Hepatic arteries to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed. Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed by cutting gel foam sheets into small pledges mannully then mixed with a contrast material and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.

DRUGTACE with Drug Eluting Beads procedure

The same was done as cTACE till the super selective catheterization of the feeding artery. Loading of the beads with Doxorubicin hydrochloride (100-150 mg) was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter (Cobra head catheter; Cordis, USA) or 2.7F microcatheter (Progreat; Terumo, Japan).

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Complete Response1 yearAssessment 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.)

Participant flow

Recruitment details

Recruitment finished and study completed Patients collected from HCC clinic full filling the inclusion criteria,Ain Shams University hospitals

Participants by arm

ArmCount
Group 1
Twenty-five patients underwent Chemoembolization with Drug eluting beads. using Drug eluting Doxorubicin hydrochloride (100-150 mg) The procedure: The same was done as cTACE till the super selective catheterization of the feeding artery. Loading of the beads with Doxorubicin hydrochloride was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter (Cobra head catheter; Cordis, USA) or 2.7F microcatheter (Progreat; Terumo, Japan).
25
Group 2
Twenty-five patients underwent conventional Chemoembolization (cTACE) using the standard TACE technique TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed. Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.
25
Total50

Baseline characteristics

CharacteristicTotalGroup 2Group 1
50 patients with HCC collected from our weekly HCC clinic, Ain Shams University Hospitals50 Participants25 Participants25 Participants
Age, Continuous56.7 Years
STANDARD_DEVIATION 6.8
56 Years
STANDARD_DEVIATION 5.5
56.7 Years
STANDARD_DEVIATION 6.8
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Egypt
50 participants25 participants25 participants
Sex: Female, Male
Female
7 Participants3 Participants4 Participants
Sex: Female, Male
Male
43 Participants22 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 251 / 25
serious
Total, serious adverse events
1 / 255 / 25

Outcome results

Primary

Number of Participants With Complete Response

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.)

Time frame: 1 year

ArmMeasureValue (NUMBER)
Group 1Number of Participants With Complete Response23 Participants
Group 2Number of Participants With Complete Response22 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026