NCT02646137

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

8.9 years

First QC Date

January 1, 2016

Last Update Submit

January 5, 2018

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of patients with successful ablation

    The total number of patients with successful ablation

    3 months

Study Arms (3)

Transarterial chemoembolization (TACE)

ACTIVE COMPARATOR

treated by transarterial chemoembolization

Drug: Transarterial chemoembolization (TACE)

Radiofrequency ablation with TACE

EXPERIMENTAL

Radiofrequency ablation combined with TACE

Procedure: Radiofrequency ablation combined with TACE

Microwave ablation combined with TACE

EXPERIMENTAL

Microwave ablation combined with TACE.

Procedure: Microwave ablation combined with TACE

Interventions

Transarterial chemoembolization (TACE)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

Also known as: Transarterial chemoembolization
Transarterial chemoembolization (TACE)
Radiofrequency ablation combined with TACEPROCEDURE

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

Radiofrequency ablation with TACE
Microwave ablation combined with TACEPROCEDURE

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

Microwave ablation combined with TACE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university hospital

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Elshazly Sheta, Professor

    Hepatology and gastroenterology dept.-Tanta

    PRINCIPAL INVESTIGATOR

  • Ferial El-kalla, Professor

    Division of Gastroenterology and Hepatology- Tanta

    PRINCIPAL INVESTIGATOR

  • Mohamed Elgharib, Professor

    Interventional radiology - Ainshams university- Egypt

    STUDY DIRECTOR

  • Abdelrahman kobtan, Consultant

    liver diseases dept.-Tanta university hospital

    STUDY CHAIR

  • Mohamed Elhendawy, Consultant

    liver diseases dept.-Tanta university hospital

    STUDY CHAIR

  • Sherief Abd-Elsalam, Consultant

    Hepatology and gastroenterology dept.-Tanta

    STUDY CHAIR

  • Ibrahim Amer, Consultant

    Liver diseases and gastroenterology dept.-Tanta university hospital

    STUDY CHAIR

Central Study Contacts

Sherief M. Abd-Elsalam, Consultant

CONTACT

00201095159522sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant liver and GIT diseases- Tanta university hospital

Study Record Dates

First Submitted

January 1, 2016

First Posted

January 5, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

EG(1)