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.
CARES-310, 2023 NCT03764293
VEGF(R) inhibitor (n=272) vs. sorafenib (n=271)
randomized controlled trial
camrelizumab and rivoceranib (=apatinib)
camrelizumab 200 mg intravenously every 2 weeks plus rivoceranib 250 mg orally once daily
sorafenib
sorafenib 400 mg orally twice daily
mHCC - 1st line (L1)
open label
95 centres across 13 countries
PFS median follow up 7.8 monthsOS IA1 median follow up 14.5 months