A Prospective Cohort Study of Patients With Hepatobiliary Cancer Treated With Immune Checkpoint Inhibitors

  • End date
    Jul 30, 2024
  • participants needed
  • sponsor
    Asan Medical Center
Updated on 14 February 2022
extrahepatic cholangiocarcinoma
biliary tract cancer


Although immune checkpoint inhibitors including nivolumab and pembrolizumab are now available for the management of hepatobiliary cancers in Korea, there is a lack of data for the efficacy and safety of these agents in the real-world setting. This study aims to prospectively evaluate the efficacy of safety of nivolumab and pembrolizumab against advanced hepatocellular carcinoma and biliary tract cancer.


Nivolumab 3 mg/kg intravenous every 2 weeks has been recently approved by US FDA for the management of patients with sorafenib-failed advanced HCC based on the promising data of Checkmate-040 phase I/II study. Although there is a lack of prospective data for pembrolizumab in biliary tract cancer except for small phase 1 trial, pembrolizumab is now available for use in Korea for the management of advanced biliary tract cancer. Because the approval of these agents was based on the small sample size, further prospective evaluation of nivolumab or pembrolizumab in patients with hepatobiliary cancer is needed.

Condition Hepatocellular Carcinoma, Biliary Tract Cancer
Treatment Nivolumab or pembrolizumab
Clinical Study IdentifierNCT03695952
SponsorAsan Medical Center
Last Modified on14 February 2022


Yes No Not Sure

Inclusion Criteria

Biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) or hepatocellular carcinoma
Planned immune checkpoint inhibitors including nivolumab or pembrolizumab
Written informed consent

Exclusion Criteria

Not available for the treatment with immune checkpoint inhibitors
Clear my responses

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