Clinical trial · Observational
Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)
Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)
- 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)
This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases From Colorectal Cancer (mCRC) | — | UNRESOLVED | — |
| Unresectable Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIRT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with unresectable HCC or unresectable liver metastases from mCRC
- description
- This cohort will include patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, who have been prescribed selective internal radiation therapy (SIRT) with SIR-Spheres per medical decision.
- interventionNames
- Device: SIRT
Primary outcomes (8)
- measure
- Progression-free survival (PFS)
- timeFrame
- 24months from LPI
- measure
- Liver PFS (LPFS)
- timeFrame
- 24months from LPI
- measure
- Overall survival (OS)
- timeFrame
- 24months from LPI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Confirmed diagnosis of: * Unresectable hepatocellular carcinoma (HCC) Or * Unresectable liver metastases from colorectal cancer (mCRC) refractory to or intolerant to chemotherapy * Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice * Planned to receive SIR-Spheres treatment to the liver for the first time * Provision of signed patient informed consent Exclusion Criteria: * Prior radiation treatment to the liver Caveat: Sequential selective internal radiation therapy (SIRT) treatment is allowed * Patients participating in any interventional clinical trial with an investigational product, device, or procedure * Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.
References
Publications (0)
Data not yet available