Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02646137
• Other study ID #: Combined TACE and RF
• Status: Recruiting
• Phase: Phase 3
• First received: January 1, 2016
• Last updated: January 5, 2018
• Start date: January 2015
• Est. completion date: December 2023

Study information

• Verified date: January 2018
• Source: Tanta University
• Contact: Sherief M. Abd-Elsalam, Consultant
• Phone: 00201095159522
• Email: sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• 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

Procedure:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Tanta university hospital	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with successful ablation	The total number of patients with successful ablation	3 months