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

Phase 2

• Conditions: Intrahepatic Cholangiocellular Carcinoma
• Interventions: Procedure: SIRT; Procedure: DEB TACE

• Registration Number: NCT01798147
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2013-02-16
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-21
• Last Update Posted: 2017-05-23
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	at the end of study

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	at the end of study
Time to progression (TTP)	at the end of study

Trial Locations

Locations (1)

Department of Diagnostic and Interventional Radiology; 🇩🇪 Mainz, Germany