sintilimab (n=99) vs. Standard of Care (SoC) (n=99)
randomized controlled trial
sintilimab
sintilimab injections every 3 weeks for a total of eight cycles
SOc
active surveillance
hepatocell cancer (HCC)
open label
China, 6 centers
ORIENT-32, 2021 NCT03794440
sintilimab (n=380) vs. sorafenib (n=191)
randomized controlled trial
Sintilimab plus IBI305 (bevaciumab biosimilar)
200mg of sintilimab intravenously over 60min, followed by 15mg/kg body weight of IBI305 bevacizumab biosimilar intravenously over 90min (the second infusion over 60min, and afterwards over 30min if no infusion reaction occurred), every 3 weeks
Sorafenib
400mg orally twice a day
mHCC - 1st line (L1)
open label
China, 50 centers
P3 / two sided alpha = 0.05. First test of PFS at alpha = 0.002, if PFS is statistically significant, the test of the OS would be at alpha = 0.05. If PFS is not statistically significant, the test of the OS would be done with alpha at 0.048.