Combined Therapy With Conventional Trans-arterial Chemoembolization (cTACE) and Microwave Ablation (MWA) for Hepatocellular Carcinoma >3-<5 cm
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Zagazig University
- Enrollment
- 278
- Primary Endpoint
- Adverse events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
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.
Investigators
Mohammad Abd Alkhalik Basha
Assistant Professor
Zagazig University
Eligibility Criteria
Inclusion Criteria
- •Solitary HCC \>3-\<5 cm
- •Absence of extra-hepatic metastases
- •Absence of a history of encephalopathy or refractory ascites
- •Child-Pugh class A or B cirrhosis.
Exclusion Criteria
- •Poor patient compliance
- •Child-Pugh class C cirrhosis
- •Severe coagulation disorders
- •Portal vein thrombosis
- •Renal impairment (6) previous local ablation therapy of HCC
Outcomes
Primary Outcomes
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
Progression-free survival
Time Frame: Three years after procedure
The progression-free survival was measured in relation to management lines.
Recurrence rate
Time Frame: 12 months after procedure
The recurrence rate was measured in relation to management lines.
Overall mortality rate
Time Frame: Three years after procedure
The mortality rate was measured in relation to management lines.
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%
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.