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.
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®
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
Unresectable metastatic liver tumors from primary colorectal cancer
Cohort
Other
Resin microspheres containing yttrium-90 (Y-90)
DeviceSIR-Spheres Y-90 resin microspheres are permanent implant and for single use only
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
Overall survival (OS)
From the day of treatment with yttrium \[90Y\] resin microspheres to the time of death due to any cause
1-yr OS
The percentage of subjects treated with yttrium \[90Y\] resin microspheres who survived at 1 year.
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.
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.
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