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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04721470
Other study ID # 6615-18-12-2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date October 20, 2020

Study information

Verified date January 2021
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 278
Est. completion date October 20, 2020
Est. primary completion date May 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Procedure:
Combined therapy
Patients undergoing combined therapy
Microwave ablation
Patients undergoing Microwave ablation
Transarterial chemoembolization
Patients undergoing Transarterial chemoembolization

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events Images were evaluated and compared for adverse events. The adverse events were recorded and classi?ed following the guidelines of the Society of Interventional Radiology Up to three years after procedure
Primary Treatment Response 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
Primary Recurrence rate The recurrence rate was measured in relation to management lines. 12 months after procedure
Primary Overall mortality rate The mortality rate was measured in relation to management lines. Three years after procedure
Primary Progression-free survival The progression-free survival was measured in relation to management lines. Three years after procedure
Primary AFP variation rate The AFP variation rate (?AFP) 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:
?AFP (%) = [(AFPbaseline-AFPpostprocedure) /AFPbaseline] ×100%
Baseline and 1-2 months after procedure
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