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

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

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

Conditions
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Intrahepatic Cholangiocellular Carcinoma

Intervention / Treatment
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* Procedure: DEB TACE
* Procedure: SIRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DEB TACE<br>Drug eluting Beads (DC Beads) loaded with Doxorubicin | Procedure: DEB TACE<br>* DEB TACE every 6 weeks until either no viable tumor or endpoint reached.<br>* Other names: Chemoembolisation;|
| Experimental: SIRT<br>Selective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres) | Procedure: SIRT<br>* Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.<br>* Other names: Radioembolisation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | at the end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | at the end of study | 
| Time to progression (TTP) |  | at the end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TACE, Cholangiocellular Carcinoma, SIRT