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

Johannes Gutenberg University (JGU)

Status and phase: Completed; Phase 4

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: DEB TACE; Procedure: SIRT

Study type: Interventional

Funder types: Other

Identifiers

NCT01798160

SIRT-TACE-HCC-Mainz-1

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

DEB TACE

Active Comparator group

Description:

Drug eluting Beads (DC Beads) loaded with Doxorubicin

Treatment:

Procedure: DEB TACE

SIRT

Experimental group

Description:

Selective Internal Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres)

Treatment:

Procedure: SIRT