Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

Zagazig University278 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

278

Conditions

Hepatocellular Carcinoma

Interventions

Combined therapyPROCEDURE

Patients undergoing combined therapy

Microwave ablationPROCEDURE

Patients undergoing Microwave ablation

Transarterial chemoembolizationPROCEDURE

Patients undergoing Transarterial chemoembolization

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: One month

Recurrence rate

The recurrence rate was measured in relation to management lines.

Time frame: 12 months after procedure

Overall mortality rate

The mortality rate was measured in relation to management lines.

Time frame: Three years after procedure

Progression-free survival

The progression-free survival was measured in relation to management lines.

Time frame: 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%

Time frame: Baseline and 1-2 months after procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.