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.
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 Type
OBSERVATIONAL
Enrollment
200
SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Liver-specific overall response rate (ORR) according to RECIST 1.1
Percentage of subjects with complete or partial responses to the liver as determined by the investigator according to liver-specific RECIST 1.1 criteria
Time frame: 24 months
Overall survival (OS)
From the day of treatment with yttrium \[90Y\] resin microspheres to the time of death due to any cause
Time frame: 24 months
1-yr OS
The percentage of subjects treated with yttrium \[90Y\] resin microspheres who survived at 1 year.
Time frame: 12 months
Progression-free survival(PFS) assessed by the investigator
Defined as the time from the date of treatment with the yttrium \[90Y\] resin microspheres to the time when disease progression or subject death from any cause during the study period was first determined by the investigator according to RECIST 1.1 criteria, whichever occurred first.
Time frame: 24 months
Liver-specific PFS assessed by the investigator
Defined as the time from the date of treatment with yttrium \[90Y\] resin microspheres until the first time progression of liver disease or death of the subject from any cause during the study period was determined by the investigator according to liver-specific RECIST 1.1 criteria, whichever occurred first.
Time frame: 24 months
ORR assessed by the investigator
Defined as the percentage of subjects with complete or partial tumor response as determined by the investigator according to RECIST 1.1 criteria
Time frame: 24 months
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Objective Duration of tumor response (DOR) assessed by the investigator
Defined as the time from the first documented objective response to tumor recurrence or death from any cause during the study period as determined by the investigator according to RECIST 1.1 criteria, whichever occurs first
Time frame: 24 months
Duration of liver-specific DOR assessed by the investigator
Defined as the time from the first documented liver objective remission to liver recurrence or death from any cause during the study period as determined by the investigator according to liver-specific RECIST 1.1 criteria, whichever occurs first
Time frame: 24 months