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atezolizumab plus bevacizumab (n=334) vs. Standard of Care (SoC) (n=334)
randomized controlled trial
atezolizumab plus bevacizumab
1200 mg intravenous atezolizumab plus intravenous bevacizumab 15 mg/kg every 3 weeks for up to 12 months or 17 cycles
active surveillance
Patients randomly allocated to active surveillance were permitted to receive crossover treatment with atezolizumab plus bevacizumabat investigator discretion on independent review facility confirmation of disease recurrence. Resection or ablation of recurrent lesions was allowed before crossover treatment.
mHCC - (neo)adjuvant (NA)
open label
34 centres in 26 countries
nivolumab plus ipilimumab (n=14) vs. nivolumab alone (n=13)
randomized controlled trial
nivolumab plus ipilimumab
480 mg of nivolumab IV every 4 weeks plus 1 mg/kg of ipilimumab IV every 6 weeks up to 4 doses before and after surgery
nivolumab
240 mg of nivolumab intravenously (IV) every 2 weeks alone
mHCC - (neo)adjuvant (NA)
Patient can have had prior treatment for HCC including prior surgery, radiation therapy, local-regional therapy (ablation or arterial directed therapies), and systemic therapy including sorafenib or chemotherapy
open design
single-center
The goal of this arm was to study if unresectable localized disease will have adequate tumor shrinkage to become resectable.
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
mHCC - (neo)adjuvant (NA)
open label
China, 6 centers
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
pembrolizumab alone (n=278) vs. placebo (n=135)
randomized controlled trial
pembrolizumab
200 mg of pembrolizumab intravenously every 3 weeks for at least 35 cycles(approximately 2 years).
placebo
saline placebo intravenously every 3 weeks for at least 35 cycles(approximately 2 years).
Both arms received BSC at the discretion of the investigator in accordance with local practices
mHCC - 2nd line (L2)
double blind
119 medical centers in 27 countries
P3/ one sided Two interim efficacy analyses and a final efficacy analysis of O. Repartition and hierarchy with OS and PFS
In this study, OS and PFS did not reach statistical significance per specified criteria.
pembrolizumab alone (n=300) vs. placebo (n=153)
randomized controlled trial
pembrolizumab
pembrolizumab: 200mg Q3W for ≤35 cycles
placebo
placebo: Q3W for ≤35 cycles
best supportive care
mHCC - 2nd line (L2)
double blind
P3 / P value boundary for OS superiority at final analysis (FA) was 0.019307. If OS was superior, PFS and ORR superiority at the second interim analysis (IA2; primary analysis timepoint for these endpoints) could be tested at boundaries of 0.013447 and 0.009139, respectively
Pembro plus BSC significantly improved OS, PFS, and ORR compared with placebo plus BSC as second-line therapy for patients from Asia with advanced HCC
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