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Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma

Primary Purpose

Liver Cancer

Status

Recruiting

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Transarterial chemoembolization (TACE)

Radiofrequency ablation combined with TACE

Microwave ablation combined with TACE

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tanta university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Transarterial chemoembolization (TACE)

Radiofrequency ablation with TACE

Microwave ablation combined with TACE

Arm Description

treated by transarterial chemoembolization

Radiofrequency ablation combined with TACE

Microwave ablation combined with TACE.

Outcomes

Primary Outcome Measures

Number of patients with successful ablation

The total number of patients with successful ablation

Secondary Outcome Measures

Full Information

NCT ID

NCT02646137

First Posted

January 1, 2016

Last Updated

January 5, 2018

Sponsor

Sherief Abd-Elsalam

Collaborators

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT02646137

Brief Title

Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma

Official Title

Comparison of Single Session Transarterial Chemoembolization Combined With Microwave Ablation or Radiofrequency Ablation in Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Recruiting

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sherief Abd-Elsalam

Collaborators

Tanta University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transarterial chemoembolization (TACE)

Arm Type

Active Comparator

Arm Description

treated by transarterial chemoembolization

Arm Title

Radiofrequency ablation with TACE

Arm Type

Experimental

Arm Description

Radiofrequency ablation combined with TACE

Arm Title

Microwave ablation combined with TACE

Arm Type

Experimental

Arm Description

Microwave ablation combined with TACE.

Intervention Type

Drug

Intervention Name(s)

Transarterial chemoembolization (TACE)

Other Intervention Name(s)

Transarterial chemoembolization

Intervention Description

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

Procedure

Intervention Name(s)

Radiofrequency ablation combined with TACE

Intervention Description

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

Intervention Name(s)

Microwave ablation combined with TACE

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients with successful ablation

Description

The total number of patients with successful ablation

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherief M. Abd-Elsalam, Consultant

Phone

00201095159522

sherif_tropical@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elshazly Sheta, Professor

Organizational Affiliation

Hepatology and gastroenterology dept.-Tanta

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ferial El-kalla, Professor

Organizational Affiliation

Division of Gastroenterology and Hepatology- Tanta

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohamed Elgharib, Professor

Organizational Affiliation

Interventional radiology - Ainshams university- Egypt

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Abdelrahman kobtan, Consultant

Organizational Affiliation

liver diseases dept.-Tanta university hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohamed Elhendawy, Consultant

Organizational Affiliation

liver diseases dept.-Tanta university hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sherief Abd-Elsalam, Consultant

Organizational Affiliation

Hepatology and gastroenterology dept.-Tanta

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ibrahim Amer, Consultant

Organizational Affiliation

Liver diseases and gastroenterology dept.-Tanta university hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Tanta university hospital

City

Tanta

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherief Abd-Elsalam

Phone

00201000040794

Sherif_tropical@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma

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