Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma

January 5, 2018 updated by: Sherief Abd-Elsalam

Comparison of Single Session Transarterial Chemoembolization Combined With Microwave Ablation or Radiofrequency Ablation in Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study

Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In recent years, transarterial chemoembolization, radio frequency ablation and microwave ablation have been accepted as treatment modalities for patients with surgically unresectable hepatocellular carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To compare between combination treatment with radiofrequency or microwave ablation followed by transarterial chemoembolization and performed in a single session.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Tanta University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child classification A or B.
  • serum albumin ≥ 3 gm/L.
  • serum bilirubin < 2.5 mg/dL.
  • platelet count ≥70,000 mm3.
  • INR ≤ 1.6.
  • serum creatinine < 2 mg/dl.
  • tumor size more than 4 cm and confined to one lobe of the liver.

Exclusion Criteria:

  • Patients with portal vein thrombosis.
  • A technically inaccessible hepatic artery.
  • Metastatic HCC.
  • More than three lesions.
  • lesions in close proximity to the portal vein (PV),inferior vena cava (IVC) or gall bladder were excluded from the study.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transarterial chemoembolization (TACE)
treated by transarterial chemoembolization
Drug: Transarterial chemoembolization (TACE)
TACE exploits the preferential hepatic arterial supply of liver tumors for targeted delivery of chemotherapeutic agents followed by embolization or reduction in arterial flow using various types of particles
Other Names:
  • Transarterial chemoembolization
Experimental: Radiofrequency ablation with TACE
Radiofrequency ablation combined with TACE
Procedure: Radiofrequency ablation combined with TACE
Radiofrequency ablation (RFA) is an alternative therapy for HCC and liver metastases that can destroy a tumor by inducing thermal injury to the tissue through electromagnetic energy deposition
Experimental: Microwave ablation combined with TACE
Microwave ablation combined with TACE.
Procedure: Microwave ablation combined with TACE
Microwave ablation (MWA) is an appealing alternative therapy for HCC in which a microwave antenna is placed directly into the tumor, emitting an electromagnetic wave which agitates water molecules in the surrounding tissue, producing friction and heat, thereby inducing cell death via coagulation necrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with successful ablation
Time Frame: 3 months
The total number of patients with successful ablation
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Collaborators

Tanta University

Investigators

  • Study Chair: Sherief Abd-Elsalam, Consultant, Hepatology and gastroenterology dept.-Tanta
  • Principal Investigator: Elshazly Sheta, Professor, Hepatology and gastroenterology dept.-Tanta
  • Principal Investigator: Ferial El-kalla, Professor, Division of Gastroenterology and Hepatology- Tanta
  • Study Director: Mohamed Elgharib, Professor, Interventional radiology - Ainshams university- Egypt
  • Study Chair: Abdelrahman kobtan, Consultant, liver diseases dept.-Tanta university hospital
  • Study Chair: Mohamed Elhendawy, Consultant, liver diseases dept.-Tanta university hospital
  • Study Chair: Ibrahim Amer, Consultant, Liver diseases and gastroenterology dept.-Tanta university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 1, 2016

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Combined TACE and RF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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