To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma
The efficacy and safety of yttrium-90 carbon microspheres versus in patients with unresectable hepatocellular carcinoma (HCC) remain unknown. This multicenter, prospective, open-label, phase 3 trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres versus conventional TACE in patients with hepatocellular carcinoma. The primary endpoint is time to progression for patients with HCC. While the secondary endpoints include the overall response rate, duration of response, local time to progression, tumor biomarkers variation, overall survival and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
RECRUITINGTime to progression (TTP)
Evaluated by the independent image review committee (CTCAE 5.0)
Time frame: From enrollment to 54 weeks after the treatment
Adverse events
Rates and degree of adverse events
Time frame: From enrollment to 54 weeks after the treatment
Severe adverse events
Rates of severe adverse events
Time frame: From the enrollment to 54 weeks after the treatment.
localized time to progression
Localized time to progression evaluated by the investigator
Time frame: From the enrollment to 54 weeks after the treatment.
Objective response rates (ORR)
Evaluated by the investigator
Time frame: From enrollment to 54 weeks after the treatment.
Overall survival (OS)
Overall survival
Time frame: From the enrollment to the death or lost to follow up.
Duration of response (DoR)
Evaluated by the investigator
Time frame: From the enrollment to 54 weeks after the treatment
Resection rate of liver target lesions
Resection rate of liver target lesions
Time frame: From enrollment to 54 weeks after the treatment.
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Tumor markers
The variation of tumor markers
Time frame: From the enrollment to 54 weeks after the treatment.