Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).

Johannes Gutenberg University (JGU)

Status and phase: Unknown; Phase 2

Conditions: Intrahepatic Cholangiocellular Carcinoma

Treatments: Procedure: SIRT; Procedure: DEB TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT01798147

SIRT-TACE-CCC-Mainz-1

Details and patient eligibility

About

Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years
• Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9)
• Tumor confined to the liver
• At least one measurable lesion in magnetic resonance imaging (MRI)
• Tumor load ≤ 50%
• Preserved liver function (Child Pugh A and B)
• ECOG performance status ≤2

Exclusion criteria

• Patients feasible for curative treatment (e.g. resection or local ablation)
• Previous TACE or SIRT
• Prior Chemotherapy
• Child Pugh stage C
• ECOG Performance Status >1
• 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 main portal vein
• Hepatofugal blood flow in the portal vein
• Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan (MAA-scan)
• Contraindications against angiography
• Pregnancy

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 Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres)

Treatment:

Procedure: SIRT