Clinical trial · Interventional
Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
NCT01798160CI-TRIAL-00019537completedPhase 4ClinicalTrials.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 Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
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 Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres)
- interventionNames
- Procedure: SIRT
Primary outcomes (2)
- measure
- Progression-free-Survival
- timeFrame
- up to three years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.