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

NCT03007225 | Completed Phase 4 Results DMC

• 1 other identifier: treatment of HCC
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

HepatoCellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.")

  1 year

Study Arms (2)

group 1 Drug eluting beads intervention

ACTIVE COMPARATOR

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

Drug: TACE with Drug Eluting Beads procedure

group 2 Conventional TACE intervention

ACTIVE COMPARATOR

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

Drug: Trans-arterial chemoembolization (TACE)

Interventions

Trans-arterial chemoembolization (TACE) DRUG

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.

Also known as: TACE

group 2 Conventional TACE intervention

TACE with Drug Eluting Beads procedure DRUG

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).

Also known as: DEB-TACE

group 1 Drug eluting beads intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Dr Iman Montasser, Assistant professor of Tropical Medicine member of HCC clinic and group , Ain Sha
• Organization: Ain Shams University

imanfawzy2@gmail.com

0020201065065333

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of tropical medicine , Ain Shams university

Study Record Dates

• First Submitted: December 24, 2016
• First Posted: January 2, 2017
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 22, 2020
• Results First Posted: September 17, 2020

Record last verified: 2020-09