To investigate the efficacy and safety of nivolumab for patients with advanced HCC undergoing EBRT
\<Treatment phase\> Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks. External beam radiotherapy begins 2-7 days after the first dose of nivolumab. The study drug is continued until disease progression, unacceptable toxicity, withdrawal of consent or study closure. \<Follow-Up phase \> After the treatment phase, subjects will undergo follow up for survival every 12 weeks (± 7 days) from the last dose or the use of other anticancer treatments and/or therapies, and the survival follow up will be performed for at least 18 months after the enrollment of the last subject. The patient will be followed for survival follow up and the use of other anticancer treatments and/or therapies. Based on the assumed dropout rate of 12%, a total of 50 subjects need to perform the study (50=44/(1-0.12))
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
* Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks. * EBRT begins 2-7 days after the first dose of nivolumab. * The follow-up phase begins when the decision to discontinue study is made. The follow-up phase is defined as the day after the end of study treatment until the day the subject dies.
National Cancer Center, Korea
Seoul, South Korea
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of treatment initiation to the date of the first observation of progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1) or death from any cause.
Time frame: through study completion, an average of 2.5 year.
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