Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).

Phase 4

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: DEB TACE; Procedure: SIRT

• Registration Number: NCT01798160
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2013-02-16
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-18
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• ≥18 years
• HCC, proven by histology or according to EASL criteria
• Intermediate stage HCC (stage B according to BCLC)
• At least one measurable lesion in magnetic resonance imaging (MRI)
• Tumor load ≤ 50%
• preserved liver function (Child Pugh A and B)

Exclusion Criteria

• Patients feasible for curative treatment (e.g. resection or local ablation)
• Previous TACE or SIRT
• Chemotherapy during the last 4 weeks
• Child Pugh stage C
• BCLC stage D
• ECOG Performance Status >0
• Tumor involvement >50% of the liver
• Extrahepatic tumor
• Serum Bilirubin >2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine >2 mg/dl; Leukocytes <3000/ml; Thrombocytes <50000/ml
• Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
• Esophageal bleeding during the last 3 months
• Hepatic encephalopathy
• Transjugular intrahepatic portosystemic shunt (TIPS)
• Infiltration or occlusion of the portal vein
• Hepatofugal blood flow in the portal vein
• Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan
• Contraindications against angiography
• Gravidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEB TACE	DEB TACE	Drug eluting Beads (DC Beads) loaded with Doxorubicin
SIRT	SIRT	Selective Internal Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres)

Primary Outcome Measures

Name	Time	Method
Progression-free-Survival	up to three years
Overall-Survival	up to three years