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Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma

S

Sherief Abd-Elsalam

Status and phase

Unknown
Phase 3

Conditions

Liver Cancer

Treatments

Procedure: Microwave ablation combined with TACE
Procedure: Radiofrequency ablation combined with TACE
Drug: Transarterial chemoembolization (TACE)

Study type

Interventional

Funder types

Other

Identifiers

NCT02646137
Combined TACE and RF

Details and patient eligibility

About

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.

Full description

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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 3 patient groups

Transarterial chemoembolization (TACE)
Active Comparator group
Description:
treated by transarterial chemoembolization
Treatment:
Drug: Transarterial chemoembolization (TACE)
Radiofrequency ablation with TACE
Experimental group
Description:
Radiofrequency ablation combined with TACE
Treatment:
Procedure: Radiofrequency ablation combined with TACE
Microwave ablation combined with TACE
Experimental group
Description:
Microwave ablation combined with TACE.
Treatment:
Procedure: Microwave ablation combined with TACE

Trial contacts and locations

1

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Central trial contact

Sherief M. Abd-Elsalam, Consultant

Data sourced from clinicaltrials.gov

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