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Completed

NCT Number: NCT04721470

Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined therapy

Procedure

Patients undergoing combined therapy

Other names: Transarterial chemoembolization + Microwave ablation

Microwave ablation

Procedure

Patients undergoing Microwave ablation

Transarterial chemoembolization

Procedure

Patients undergoing Transarterial chemoembolization

Primary outcomes

  1. Adverse events

    Time frame: 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

  2. Treatment Response

    Time frame: 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.

  3. Recurrence rate

    Time frame: 12 months after procedure

    The recurrence rate was measured in relation to management lines.

  4. Overall mortality rate

    Time frame: Three years after procedure

    The mortality rate was measured in relation to management lines.

  5. Progression-free survival

    Time frame: Three years after procedure

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

  6. AFP variation rate

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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