Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Microwave ablation; Procedure: Combined therapy; Procedure: Transarterial chemoembolization

• Registration Number: NCT04721470
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-05-15
• Study Completion: 2020-10-20
• Status Verified: 2021-01
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-21
• Last Update Submitted: 2021-01-21
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microwave ablation	Microwave ablation	Patients undergoing Microwave ablation
Combined therapy	Combined therapy	Patients undergoing combined therapy
Transarterial chemoembolization	Transarterial chemoembolization	Patients undergoing Transarterial chemoembolization

Primary Outcome Measures

Name	Time	Method
Overall mortality rate	Three years after procedure	The mortality rate was measured in relation to management lines.
Adverse events	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	Three years after procedure	The progression-free survival was measured in relation to management lines.
Recurrence rate	12 months after procedure	The recurrence rate was measured in relation to management lines.
AFP variation rate	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	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.