Clinical trial · Interventional
Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis
A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma
- 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)
Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver metastases in patients with advanced uveal melanoma with respect to progression-free survival and exploratory comparison of secondary endpoints regarding application, activity, adverse effects and impact on quality of life in a randomized study design.
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 |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DSM-TACE | Procedure | — | UNRESOLVED |
| SIRT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- SIRT: Transarterial radioembolisation with Yttrium-90-bearing resin microspheres (SIR-Spheres®)
- interventionNames
- Procedure: SIRT
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- DSM-TACE: Transarterial chemoembolisation with Cisplatin and EmboCept® S starch microspheres (PharmaCept GmbH)
- interventionNames
- Procedure: DSM-TACE
Primary outcomes (1)
- measure
- Pregression-free survival (PFS)
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria (main): * ECOG Performance Status of 0, 1 or 2 * Histologically or cytologically confirmed liver metastases of uveal melanoma * At least one measurable lesion according to RECIST criteria v1.1 determined MRI (if contraindications against MRI exist CT with contrast media can is allowed) * Metastases in other sides are allowed if not in need of treatment (e.g. asymptomatic bone metastasis without indication for radiation) * Prior treatment with systemic anti-cancer therapy is allowed if terminated ≥ 4 weeks prior to study treatment start and recovery from toxicity is achieved * Surgery in general and hepatic surgery in particular (e.g. lobe resection, radiofrequency ablation) prior to study enrollment are allowed if realized ≥ 4 weeks prior to study enrollment and recovery from surgery is achieved Exclusion Criteria (main): * Surgically treatable liver metastases * Previous intraarterial hepatic treatment (e.g. radioembolisation, chemoembolisation, intraarterial chemotherapy, isolated or percutaneous hepatic perfusion) * Previous treatment with external liver radiation * Major intrahepatic occlusion of the portal vein and/or tumor infiltration of the portal vein * Liver cirrhosis Child-Pugh C * Progressive liver failure * Renale failure, bone marrow insufficiency, coagulopathy * Uncontrolled or severe medical conditions which could impair the ability to participate in the trial such as unstable cardiac disease or uncontrolled infection * Other malignancy and/or metastases in need of treatment * Current treatment with any anti-cancer therapy
References
Publications (0)
Data not yet available