Status:
NOT_YET_RECRUITING
Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
Lead Sponsor:
GrandPharma (China) Co., Ltd.
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
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 (...
Detailed Description
This is a post-market trial evaluating the efficacy and safety of SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable metastatic liver tumors from primary colorectal cancer. Patient...
Eligibility Criteria
Inclusion
- Obtained informed consent for patients to be follow-up prospectively
- Age≥18 years old
- Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care
- Received SIR-Spheres®
Exclusion
- Special contraindications from package insert, which includes
- Markedly abnormal liver function tests, such as total bilirubin \> 2.0 mg/dL or albumin \<3.0 g/dL
- Portal vein thrombosis in the main trunk
- Disseminated extrahepatic disease
- Previous external beam radiation therapy to the liver
- Women are lactating or pregnant during the study or plan to be pregnant during the study
- Patients with mental illness or cognitive impairment
- Per investigator, patients are non-adherent or reluctant to be followed up
Key Trial Info
Start Date :
October 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06079242
Start Date
October 15 2023
End Date
April 1 2027
Last Update
October 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310002