Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

January 21, 2021 updated by: Mohammad Abd Alkhalik Basha, Zagazig University

Combined Therapy With Conventional Trans-arterial Chemoembolization (cTACE) and Microwave Ablation (MWA) for Hepatocellular Carcinoma >3-<5 cm

The purpose of this study is to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE) + microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm.

This randomized controlled trial screened 278 patients with HCC >3-<5 cm. Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or MRI. Images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP) concentration was measured at baseline and during every follow-up visit.

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Solitary HCC >3-<5 cm
  2. Absence of extra-hepatic metastases
  3. Absence of a history of encephalopathy or refractory ascites
  4. Child-Pugh class A or B cirrhosis.

Exclusion Criteria:

  1. Poor patient compliance
  2. Child-Pugh class C cirrhosis
  3. Severe coagulation disorders
  4. Portal vein thrombosis
  5. Renal impairment (6) previous local ablation therapy of HCC

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
Experimental: Combined therapy
Patients undergoing combined therapy
Procedure: Combined therapy
Patients undergoing combined therapy
Other Names:
  • Transarterial chemoembolization + Microwave ablation
Active Comparator: Transarterial chemoembolization
Patients undergoing Transarterial chemoembolization
Procedure: Transarterial chemoembolization
Patients undergoing Transarterial chemoembolization
Active Comparator: Microwave ablation
Patients undergoing Microwave ablation
Procedure: Microwave ablation
Patients undergoing Microwave ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Up to three years after procedure
Images were evaluated and compared for adverse events. The adverse events were recorded and classified following the guidelines of the Society of Interventional Radiology
Up to three years after procedure
Treatment Response
Time Frame: One month
Tumor response was evaluated by CECT or dynamic MRI based on the modified response evaluation criteria in solid tumor (m-RECIST) established by the American Association for the Study of Liver Diseases.
One month
Recurrence rate
Time Frame: 12 months after procedure
The recurrence rate was measured in relation to management lines.
12 months after procedure
Overall mortality rate
Time Frame: Three years after procedure
The mortality rate was measured in relation to management lines.
Three years after procedure
Progression-free survival
Time Frame: Three years after procedure
The progression-free survival was measured in relation to management lines.
Three years after procedure
AFP variation rate
Time Frame: Baseline and 1-2 months after procedure

The AFP variation rate (ΔAFP) was defined as the percentage of change between the AFP concentration at baseline and the postprocedure AFP concentration after 1-2 months as shown in the following equation:

ΔAFP (%) = [(AFPbaseline-AFPpostprocedure) /AFPbaseline] ×100%
Baseline and 1-2 months after procedure

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Mohammad A Basha, Professor, Zagazig University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2017

Primary Completion (Actual)

May 15, 2020

Study Completion (Actual)

October 20, 2020

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6615-18-12-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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