click on circles to display study description...
atezolizumab plus bevacizumab (n=336) vs. sorafenib (n=165)
randomized controlled trial
atezolizumab-bevacizumab
atezolizumab–bevacizumab group received 1200 mg of atezolizumab plus 15 mg per kilogram of body weight of bevacizumab intravenously every 3 weeks
sorafenib
400 mg of sorafenib orally twice daily
Dose modifications were not permitted in the atezolizumab–bevacizumab group but were allowed in the sorafenib group.
mHCC - 1st line (L1)
open design
111 sites in 17 countries
P3/two sided One analysis of PFS, two interim analyses, and a final analysis of OS. Repartition, reallocation and hierarchy OS PFS and ORR (arm A then arm B)
In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progressionfree survival outcomes than sorafenib
atezolizumab plus cabozantinib (n=432) vs. sorafenib (n=217)
randomized controlled trial
cabozantinib plus atezolizumab
cabozantinib (orally) at 40 mg once daily, and atezolizumab intravenously at 1200 mg every 3 weeks
sorafenib
sorafenib 400 mg twice daily
mHCC - 1st line (L1)
open label
178 centres in 32 countries
P3 / PFS (cabozantinib plus atezolizumab vs sorafenib in ITT pop) and OS (c a vs s) in ITT pop / PFS (cabozantinib alone vs sorafenib in ITT pop)
camrelizumab based treatment (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
durvalumab plus bevacizumab (n=204) vs. placebo (n=205)
randomized controlled trial
Durvalumab and Bevacizumab
ACE and then Durvalumab/Bevacizumab
placebo
TACE and then placebo
3 arms TACE and then Durvalumab/Bevacizumab; TACE and then durvalumab/placebo; TACE and then placebo
mHCC - 1st line (L1)
double-blind
results from press release
durvalumab plus tremelimumab (n=393) vs. sorafenib (n=389)
randomized controlled trial
durvalumab and tremelimumab
tremelimumab 300 mg in combination with durvalumab 1,500 mg followed by durvalumab 1,500 mg every 4 weeks
sorafenib
sorafenib 400 mg twice daily
3 arms : a single dose of tremelimumab 300 mg in combination with durvalumab 1,500 mg followed by durvalumab 1,500 mg every 4 weeks,durvalumab 1,500 mg every 4 weeks monotherapy sorafenib 400 mg twice daily
mHCC - 1st line (L1)
open design
181 sites in 16 countries
Originally, there were four treatment groups with patients randomly assigned 1:1:1:1. Enrollement in T75 D arm (75 mg of tremelimumab every 4 weeks for four doses plus 1500 mg of durvalumab every 4 weeks) was closed regarding results from Study 22. The protocol was amended to randomly assign patients 1:1:1 to receive STRIDE, durvalumab, or sorafenib
nivolumab alone (n=371) vs. sorafenib (n=372)
randomized controlled trial
nivolumab
NIVO 240 mg IV Q2W
sorafenib
Sorafenib (400 mg oral BID).
mHCC - 1st line (L1)
open label
at medical centres in 22 countries and territories in Asia, Australasia, Europe, and North America
P3 / OS at 2-sided at 0.05 with one IA (at 0.024) and one final analysis (at 0.043). Hierarchical testing: OS > ORR > PFS
this study did not meet its primary endpoint OS
nivolumab plus ipilimumab plus SoC (n=-9) vs. VEGF(R) inhibitor (n=-9)
randomized controlled trial
nivolumab and ipilimumab
Opdivo 1mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg Q4W
sorafenib or lenvatinib (investigator's choice)
mHCC - 1st line (L1)
open-label
results from press release 03/20/2024
pembrolizumab plus lenvatinib (n=395) vs. lenvatinib (n=399)
randomized controlled trial
lenvatinib in combination with pembrolizumab
lenvatinib (bodyweight <60 kg, 8 mg/day; bodyweight ≥60 kg, 12 mg/day) plus pembrolizumab (200 mg every 3 weeks)
Lenvatinib
lenvatinib (bodyweight <60 kg, 8 mg/day; bodyweight ≥60 kg, 12 mg/day) placebo
mHCC - 1st line (L1)
double blind
172 sites
study Misses Primary End Points
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.
Tislelizumab (n=342) vs. sorafenib (n=332)
randomized controlled trial
tislelizumab
200 mg IV once every 3 weeks
sorafenib
400 mg twice daily (BID) po
mHCC - 1st line (L1)
Geographic region : asia (excluding Japan) 63%; Japan 11%; rest of world 26%
open label
117 centers, 11 countries
powered by vis.js Network