Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079242
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-13
First Post:
2023-09-22
Brief Title:
Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
Sponsor:
GrandPharma China Co Ltd
Organization:
GrandPharma China Co Ltd
Study Overview
Official Title:
Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 Patients enrolled should already complete the infusion of SIR-Spheres and data are about to be collected both retrospectively and prospectively 200 patients are anticipated to be enrolled and followed up for up to 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None