Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

NCT ID: NCT04721470

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-10-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combined therapy

Patients undergoing combined therapy

Group Type EXPERIMENTAL

Combined therapy

Intervention Type PROCEDURE

Patients undergoing combined therapy

Transarterial chemoembolization

Patients undergoing Transarterial chemoembolization

Group Type ACTIVE_COMPARATOR

Transarterial chemoembolization

Intervention Type PROCEDURE

Patients undergoing Transarterial chemoembolization

Microwave ablation

Patients undergoing Microwave ablation

Group Type ACTIVE_COMPARATOR

Microwave ablation

Intervention Type PROCEDURE

Patients undergoing Microwave ablation

Interventions

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Combined therapy

Patients undergoing combined therapy

Intervention Type PROCEDURE

Microwave ablation

Patients undergoing Microwave ablation

Intervention Type PROCEDURE

Transarterial chemoembolization

Patients undergoing Transarterial chemoembolization

Intervention Type PROCEDURE

Other Intervention Names

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Transarterial chemoembolization + Microwave ablation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mohammad Abd Alkhalik Basha

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad A Basha, Professor

Role: PRINCIPAL_INVESTIGATOR

Zagazig University, Egypt

References

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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.

Reference Type DERIVED
PMID: 33615957 (View on PubMed)

Other Identifiers

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6615-18-12-2016

Identifier Type: -

Identifier Source: org_study_id

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