A Prospective Cohort Study of Patients With Hepatobiliary Cancer Treated With Immune Checkpoint Inhibitors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Biliary Tract Cancer
- Hepatocellular Carcinoma
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
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 exc...
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.
Tracking Information
- NCT #
- NCT03695952
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Changhoon Yoo, MD Asan Medical Center
Get Well Soon