Clinical trial · Observational
Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
NCT06079242CI-TRIAL-00070473not yet recruitingClinicalTrials.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)
This real-world study tries to collect data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable liver metastases from Metastatic Liver Tumors From Primary Colorectal Cancer (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 in China.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Resin microspheres containing yttrium-90 (Y-90) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Liver-specific overall response rate (ORR) according to RECIST 1.1
- timeFrame
- 24 months
- description
- Percentage of subjects with complete or partial responses to the liver as determined by the investigator according to liver-specific RECIST 1.1 criteria
Secondary outcomes (7)
- measure
- Overall survival (OS)
- timeFrame
- 24 months
- description
- From the day of treatment with yttrium \[90Y\] resin microspheres to the time of death due to any cause
- measure
- 1-yr OS
- timeFrame
- 12 months
- description
- The percentage of subjects treated with yttrium \[90Y\] resin microspheres who survived at 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Obtained informed consent for patients to be follow-up prospectively 2. Age≥18 years old 3. Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care 4. Received SIR-Spheres® Exclusion Criteria: 1. Special contraindications from package insert, which includes 1. Markedly abnormal liver function tests, such as total bilirubin \> 2.0 mg/dL or albumin \<3.0 g/dL 2. Portal vein thrombosis in the main trunk 3. Disseminated extrahepatic disease 4. Previous external beam radiation therapy to the liver 2. Women are lactating or pregnant during the study or plan to be pregnant during the study 3. Patients with mental illness or cognitive impairment 4. Per investigator, patients are non-adherent or reluctant to be followed up
References
Publications (0)
Data not yet available
No reference posted for this study.