Study study type PathologyT1T0Patientssample sizesROB Results

hepatocell cancer (HCC) hepatocell cancer (HCC)

versus Standard of Care (SoC)
sintilimab
Wang, 2024
  ChiCTR2000037655
RCThepatocell cancer (HCC), mHCC - (neo)adjuvant (NA)sintilimabSOc99 / 99NA
conclusif
  • demonstrated 47 % decrease in RFS/DFS (PE)
  • statistically significant 200.0-fold increase in AE (any grade)
  • statistically significant 26.2-fold increase in AE (grade 3-4)

mHCC - (neo)adjuvant (NA) metastatic/advanced hepatocellular cancer (mHCC) mHCC - (neo)adjuvant (NA)

versus Standard of Care (SoC)
sintilimab
Wang, 2024
  ChiCTR2000037655
RCThepatocell cancer (HCC), mHCC - (neo)adjuvant (NA)sintilimabSOc99 / 99NA
conclusif
  • demonstrated 47 % decrease in RFS/DFS (PE)
  • statistically significant 200.0-fold increase in AE (any grade)
  • statistically significant 26.2-fold increase in AE (grade 3-4)

mHCC - 1st line (L1) metastatic/advanced hepatocellular cancer (mHCC) mHCC - 1st line (L1)

versus sorafenib
sintilimab
ORIENT-32, 2021
 
NCT03794440
RCTmHCC - 1st line (L1)Sintilimab plus IBI305 (bevaciumab biosimilar)Sorafenibpatients with unresectable, locally advanced, or metastatic hepato cellular carcinoma, with a diagnosis that was histologically, cytologically, or clinically confirmed, who had received no previous systemic therapy for advanced or metastatic disease, or were unsuitable for radical surgery or had local treatment stage B380 / 191low
conclusif
  • demonstrated 43 % decrease in deaths (OS) (PE)