Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721470
• Other study ID #: 6615-18-12-2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: October 20, 2020

Study information

• Verified date: January 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: October 20, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Combined therapy
Patients undergoing combined therapy
• Microwave ablation
Patients undergoing Microwave ablation
• Transarterial chemoembolization
Patients undergoing Transarterial chemoembolization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Images were evaluated and compared for adverse events. The adverse events were recorded and classi?ed following the guidelines of the Society of Interventional Radiology	Up to three years after procedure
Primary	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
Primary	Recurrence rate	The recurrence rate was measured in relation to management lines.	12 months after procedure
Primary	Overall mortality rate	The mortality rate was measured in relation to management lines.	Three years after procedure
Primary	Progression-free survival	The progression-free survival was measured in relation to management lines.	Three years after procedure
Primary	AFP variation rate	The AFP variation rate (?AFP) 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: ?AFP (%) = [(AFPbaseline-AFPpostprocedure) /AFPbaseline] ×100%	Baseline and 1-2 months after procedure