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

Asan Medical Center

Status

Active, not recruiting

Conditions

Biliary Tract Cancer

Hepatocellular Carcinoma

Treatments

Drug: Nivolumab or pembrolizumab

Study type

Observational

Funder types

Other

Identifiers

NCT03695952

ICI_Biomarker

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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