Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma

Phase 3

• Conditions: Liver Cancer
• Interventions: Drug: Transarterial chemoembolization (TACE); Procedure: Radiofrequency ablation combined with TACE; Procedure: Microwave ablation combined with TACE

• Registration Number: NCT02646137
• Lead Sponsor: Sherief Abd-Elsalam

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-01-01
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transarterial chemoembolization (TACE)	Transarterial chemoembolization (TACE)	treated by transarterial chemoembolization
Radiofrequency ablation with TACE	Radiofrequency ablation combined with TACE	Radiofrequency ablation combined with TACE
Microwave ablation combined with TACE	Microwave ablation combined with TACE	Microwave ablation combined with TACE.

Primary Outcome Measures

Name	Time	Method
Number of patients with successful ablation	3 months	The total number of patients with successful ablation

Trial Locations

Locations (1)

Tanta university hospital; 🇪🇬 Tanta, Egypt