NCT04721470

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable hepatocellular-carcinoma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

3.4 years

First QC Date

January 20, 2021

Last Update Submit

January 21, 2021

Conditions

Hepatocellular Carcinoma

Keywords

Combined therapy; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (3)

Combined therapy

EXPERIMENTAL

Patients undergoing combined therapy

Procedure: Combined therapy

Transarterial chemoembolization

ACTIVE COMPARATOR

Patients undergoing Transarterial chemoembolization

Procedure: Transarterial chemoembolization

Microwave ablation

ACTIVE COMPARATOR

Patients undergoing Microwave ablation

Procedure: Microwave ablation

Interventions

Combined therapyPROCEDURE

Patients undergoing combined therapy

Also known as: Transarterial chemoembolization + Microwave ablation
Combined therapy
Microwave ablationPROCEDURE

Patients undergoing Microwave ablation

Microwave ablation
Transarterial chemoembolizationPROCEDURE

Patients undergoing Transarterial chemoembolization

Transarterial chemoembolization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Poor patient compliance
  • Child-Pugh class C cirrhosis
  • Severe coagulation disorders
  • Portal vein thrombosis
  • Renal impairment (6) previous local ablation therapy of HCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zaitoun MMA, Elsayed SB, Zaitoun NA, Soliman RK, Elmokadem AH, Farag AA, Amer M, Hendi AM, Mahmoud NEM, Salah El Deen D, Alsowey AM, Shahin S, Basha MAA. Combined therapy with conventional trans-arterial chemoembolization (cTACE) and microwave ablation (MWA) for hepatocellular carcinoma >3-<5 cm. Int J Hyperthermia. 2021;38(1):248-256. doi: 10.1080/02656736.2021.1887941.

    PMID: 33615957DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Psychotherapy, Multiple

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mohammad A Basha, Professor

    Zagazig University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3).
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 22, 2021

Study Start

January 1, 2017

Primary Completion

May 15, 2020

Study Completion

October 20, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share