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

Sponsor
Asan Medical Center
Study ID
NCT03695952
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 1, 2018
Status verified
Jan 2025
Primary completion
Jul 30, 2025
Completion
Jul 30, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Hepatocellular carcinoma
    Hepatocellular carcinoma patients treated with nivolumab
  • Arm: Biliary Tract Cancer
    Biliary tract cancer patients treated with pembrolizumab

Primary Outcome Measure

Objective response rate [ Time Frame: 6 months ]

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