To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable hepatocellular carcinoma
The efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable hepatocellular carcinoma 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 hepatocellular carcinoma. The primary endpoints are safety and local objective response rate of liver target lesions. While the secondary endpoints include the time to progression, progression-free survival rates, disease control rates, duration of response, quality of life and the distribution characteristics of yttrium-90 carbon microspheres.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres
Gao-Jun Teng
Nanjing, China
RECRUITINGAdverse events
Rates of adverse events
Time frame: Up to 24 months
Objective response rates (ORR)
Liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 5.0)
Time frame: 3 months after yttrium-90 injection
Hepatic time to progression (hTTP)
Time to progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 5.0)
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.
Time frame: Within 24 hours
Progression Free Survival Rate (PFS)
Survival probability of patients without imaging progression of liver target lesions
Time frame: 3 months after yttrium-90 injection
Time to progression (TTP)
Time with tumor progression, evaluated by the investigator and independent image review committee respectively (CTCAE 5.0)
Time frame: Up to 24 months
Disease control rate (DCR)
Probability of tumor control
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 5.0)
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Time frame: Up to 24 months
Alpha fetoprotein (AFP)
The variation of AFP levels
Time frame: Up to 24 months
Quality of life (QoL)
The variation of QoL with EORCT QLQ-C30
Time frame: Up to 24 months
Resection rate of liver target lesions
Resection rate of liver target lesions
Time frame: Within 6 months