Clinical trial · Interventional
Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
NCT01798147CI-TRIAL-00027753unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocellular Carcinoma | Intrahepatic Cholangiocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEB TACE | Procedure | — | UNRESOLVED |
| SIRT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- DEB TACE
- description
- Drug eluting Beads (DC Beads) loaded with Doxorubicin
- interventionNames
- Procedure: DEB TACE
- type
- EXPERIMENTAL
- label
- SIRT
- description
- Selective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres)
- interventionNames
- Procedure: SIRT
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- at the end of study
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKloeckner R, Ruckes C, Kronfeld K, Worns MA, Weinmann A, Galle PR, Lang H, Otto G, Eichhorn W, Schreckenberger M, Dueber C, Pitton MB. Selective internal radiotherapy (SIRT) versus transarterial chemoembolization (TACE) for the treatment of intrahepatic cholangiocellular carcinoma (CCC): study protocol for a randomized controlled trial. Trials. 2014 Aug 6;15:311. doi: 10.1186/1745-6215-15-311. PMID 25095718