Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma

NCT ID: NCT02646137

Last Updated: 2018-01-09

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2023-12-31

Brief Summary

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Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In recent years, transarterial chemoembolization, radio frequency ablation and microwave ablation have been accepted as treatment modalities for patients with surgically unresectable hepatocellular carcinoma.

Detailed Description

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To compare between combination treatment with radiofrequency or microwave ablation followed by transarterial chemoembolization and performed in a single session.

Conditions

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Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transarterial chemoembolization (TACE)

treated by transarterial chemoembolization

Group Type ACTIVE_COMPARATOR

Transarterial chemoembolization (TACE)

Intervention Type DRUG

TACE exploits the preferential hepatic arterial supply of liver tumors for targeted delivery of chemotherapeutic agents followed by embolization or reduction in arterial flow using various types of particles

Radiofrequency ablation with TACE

Radiofrequency ablation combined with TACE

Group Type EXPERIMENTAL

Radiofrequency ablation combined with TACE

Intervention Type PROCEDURE

Radiofrequency ablation (RFA) is an alternative therapy for HCC and liver metastases that can destroy a tumor by inducing thermal injury to the tissue through electromagnetic energy deposition

Microwave ablation combined with TACE

Microwave ablation combined with TACE.

Group Type EXPERIMENTAL

Microwave ablation combined with TACE

Intervention Type PROCEDURE

Microwave ablation (MWA) is an appealing alternative therapy for HCC in which a microwave antenna is placed directly into the tumor, emitting an electromagnetic wave which agitates water molecules in the surrounding tissue, producing friction and heat, thereby inducing cell death via coagulation necrosis

Interventions

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Transarterial chemoembolization (TACE)

TACE exploits the preferential hepatic arterial supply of liver tumors for targeted delivery of chemotherapeutic agents followed by embolization or reduction in arterial flow using various types of particles

Intervention Type DRUG

Radiofrequency ablation combined with TACE

Radiofrequency ablation (RFA) is an alternative therapy for HCC and liver metastases that can destroy a tumor by inducing thermal injury to the tissue through electromagnetic energy deposition

Intervention Type PROCEDURE

Microwave ablation combined with TACE

Microwave ablation (MWA) is an appealing alternative therapy for HCC in which a microwave antenna is placed directly into the tumor, emitting an electromagnetic wave which agitates water molecules in the surrounding tissue, producing friction and heat, thereby inducing cell death via coagulation necrosis

Intervention Type PROCEDURE

Other Intervention Names

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Transarterial chemoembolization

Eligibility Criteria

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Inclusion Criteria

* Child classification A or B.
* serum albumin ≥ 3 gm/L.
* serum bilirubin \< 2.5 mg/dL.
* platelet count ≥70,000 mm3.
* INR ≤ 1.6.
* serum creatinine \< 2 mg/dl.
* tumor size more than 4 cm and confined to one lobe of the liver.

Exclusion Criteria

* Patients with portal vein thrombosis.
* A technically inaccessible hepatic artery.
* Metastatic HCC.
* More than three lesions.
* lesions in close proximity to the portal vein (PV),inferior vena cava (IVC) or gall bladder were excluded from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Consultant liver and GIT diseases- Tanta university hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Elshazly Sheta, Professor

Role: PRINCIPAL_INVESTIGATOR

Hepatology and gastroenterology dept.-Tanta

Ferial El-kalla, Professor

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology and Hepatology- Tanta

Mohamed Elgharib, Professor

Role: STUDY_DIRECTOR

Interventional radiology - Ainshams university- Egypt

Abdelrahman kobtan, Consultant

Role: STUDY_CHAIR

liver diseases dept.-Tanta university hospital

Mohamed Elhendawy, Consultant

Role: STUDY_CHAIR

liver diseases dept.-Tanta university hospital

Sherief Abd-Elsalam, Consultant

Role: STUDY_CHAIR

Hepatology and gastroenterology dept.-Tanta

Ibrahim Amer, Consultant

Role: STUDY_CHAIR

Liver diseases and gastroenterology dept.-Tanta university hospital

Locations

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Tanta university hospital

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief M. Abd-Elsalam, Consultant

Role: CONTACT

00201095159522

Facility Contacts

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Sherief Abd-Elsalam

Role: primary

00201000040794

Other Identifiers

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Combined TACE and RF

Identifier Type: -

Identifier Source: org_study_id

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