Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Combined therapy
* Procedure: Microwave ablation
* Procedure: Transarterial chemoembolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined therapy<br>Patients undergoing combined therapy | Procedure: Combined therapy<br>* Patients undergoing combined therapy<br>* Other names: Transarterial chemoembolization + Microwave ablation;|
| Active Comparator: Transarterial chemoembolization<br>Patients undergoing Transarterial chemoembolization | Procedure: Transarterial chemoembolization<br>* Patients undergoing Transarterial chemoembolization<br>|
| Active Comparator: Microwave ablation<br>Patients undergoing Microwave ablation | Procedure: Microwave ablation<br>* Patients undergoing Microwave ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 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 | 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 | The recurrence rate was measured in relation to management lines. | 12 months after procedure | 
| Overall mortality rate | The mortality rate was measured in relation to management lines. | Three years after procedure | 
| Progression-free survival | The progression-free survival was measured in relation to management lines. | Three years after procedure | 
| AFP variation rate | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combined therapy; hepatocellular carcinoma