To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases
The efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases remain unknown. This multicentre, prospective, open-label, single-arm trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases. The primary endpoints are the progression-free survival rates of liver target lesions. While the secondary endpoints include the safety, tumor control, and the distribution characteristics of yttrium-90 carbon microspheres.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Yttrium-90 carbon microspheres SIRT
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
RECRUITINGProgression Free Survival Rate of Liver Target Lesions
Survival probability of patients without imaging progression of liver target lesions
Time frame: 3 months after yttrium-90 injection
Adverse events
Rate of adverse events
Time frame: Up to 24 months
Yttrium-90 distribution
Assessed by SPECT-CT imaging in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available)
Time frame: Within 24 hours
Objective response rate (ORR)
Evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time frame: Up to 24 months
Duration of response (DOR)
Time without imaging progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time frame: Up to 24 months
Hepatic progression-free survival (hPFS)
Time without imaging progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time frame: Up to 24 months
Time to progression (TTP)
Time with tumor progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time frame: Up to 24 months
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Progression-free survival (PFS)
Evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time frame: Up to 24 months
Overall survival (OS)
Survival time
Time frame: Up to 24 months
Disease control rate (DCR)
Probability of tumor control
Time frame: Up to 24 months