Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

Zagazig University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Transarterial chemoembolization; Procedure: Microwave ablation; Procedure: Combined therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04721470

6615-18-12-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 278 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 3 patient groups

Combined therapy

Experimental group

Description:

Patients undergoing combined therapy

Treatment:

Procedure: Combined therapy

Transarterial chemoembolization

Active Comparator group

Description:

Patients undergoing Transarterial chemoembolization

Treatment:

Procedure: Transarterial chemoembolization

Microwave ablation

Active Comparator group

Description:

Patients undergoing Microwave ablation

Treatment:

Procedure: Microwave ablation