Study study type PathologyT1T0Patientssample sizesROB Results

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

versus nivolumab alone
nivolumab plus ipilimumab
NCI-2018-01106, 2022
  NCT03222076
RCThepatocell cancer (HCC)nivolumab plus ipilimumabnivolumabPatients With Resectable and Potentially Resectable14 / 13NA
inconclusive
    no statistically significant result
versus Standard of Care (SoC)
atezolizumab plus bevacizumab
IMbrave050, 2023
  NCT04102098
RCTmHCC - (neo)adjuvant (NA)atezolizumab plus bevacizumabactive surveillanceadult patients with high-risk surgically resected or ablated hepatocellular carcinoma334 / 334NA
conclusif
  • demonstrated 28 % decrease in RFS/DFS (PE)
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 lenvatinib
pembrolizumab plus lenvatinib
LEAP 002, 2023
  NCT03713593
RCTmHCC - 1st line (L1)lenvatinib in combination with pembrolizumabLenvatinibfirst-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants395 / 399low
inconclusive
  • inconclusive 16 % decrease in deaths (OS),deaths (OS) (PE)
  • inconclusive 13 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
versus placebo
durvalumab plus bevacizumab
EMERALD-1, 2024
  NCT03778957
RCThepatocell cancer (HCC)Durvalumab and Bevacizumabplacebopatients with locoregional hepatocellular carcinoma204 / 205NA
conclusif
  • demonstrated 23 % decrease in progression or deaths (PFS) (PE)
versus sorafenib
atezolizumab plus bevacizumab
IMbrave-150, 2020
  NCT03434379
RCTmHCC - 1st line (L1)atezolizumab-bevacizumabsorafenibpatients with unresectable hepatocellular carcinoma who had not previously received systemic treatment336 / 165some concern
conclusif
  • demonstrated 42 % decrease in deaths (OS) (PE)
  • demonstrated 41 % decrease in progression or deaths (PFS) (PE)
  • demonstrated 1.8-fold increase in objective responses (ORR) (PE)
atezolizumab plus cabozantinib
COSMIC-312, 2023
  NCT03755791
RCTmHCC - 1st line (L1)cabozantinib plus atezolizumabsorafenibSubjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy432 / 217NA
trade-off
  • inconclusive 2 % decrease in deaths (OS) (PE)
  • demonstrated 37 % decrease in progression or deaths (PFS) (PE)
bevacizumab, 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),deaths (OS) (PE)
durvalumab plus tremelimumab
HIMALAYA, 2022
  NCT03298451
RCTmHCC - 1st line (L1)durvalumab and tremelimumabsorafenibunresectable hepatocellular carcinoma who were naive to previous systemic treatment393 / 389low
conclusif
  • demonstrated 22 % decrease in deaths (OS) (PE)
  • suggested 22 % decrease in deaths (OS) (extension)
nivolumab alone
CheckMate 459, 2019
  NCT02576509
RCTmHCC - 1st line (L1)nivolumabsorafenibfirst-line (1L) treatment in patients (pts) with advanced hepatocellular carcinoma (aHCC) / patients (at least 18yr) with hiistologically confirmed advanced hepatocellular carcinoma ot eligible for, or whose disease had progressed after, surgical or locoregional therapies371 / 372some concern
suggested
  • inconclusive 15 % decrease in deaths (OS) (PE)
Tislelizumab
RATIONALE 301, 2024
  NCT03412773
RCThepatocell cancer (HCC)tislelizumabsorafenibfirst-line treatment of unresectable hepatocellular carcinoma (HCC)342 / 332NA
inconclusive
  • inconclusive 15 % decrease in deaths (OS) (PE)
non inferiority for OS demonstrate but superiority threshold not met
camrelizumab based treatment, VEGF(R) inhibitor
CARES-310, 2023
  NCT03764293
RCTmHCC - 1st line (L1)camrelizumab and rivoceranib (=apatinib)sorafenibadult with confirmed hepatocellular carcinoma; had Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to or had progressed after surgical or locoregional therapy; and had not previously received any systemic therapy272 / 271NA
conclusif
  • demonstrated 38 % decrease in deaths (OS),deaths (OS) (PE)
  • demonstrated 48 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
  • suggested 46 % decrease in PFS (extension),PFS (extension)

mHCC - 2nd line (L2) metastatic/advanced hepatocellular cancer (mHCC) mHCC - 2nd line (L2)

versus placebo
pembrolizumab alone
KEYNOTE-240, 2020
  NCT02702401
RCTmHCC - 2nd line (L2)pembrolizumabplacebopreviously treated patients with advanced hepatocellular carcinoma (HCC)278 / 135low
inconclusive
  • suggested 22 % decrease in deaths (OS),deaths (OS) (PE)
  • suggested 28 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)