A Prospective Cohort Study of Patients with Hepatobiliary Cancer Treated with Immune Checkpoint Inhibitors
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
ExpectedJanuary 28, 2025
January 1, 2025
7.1 years
October 3, 2018
January 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate
Proportion of complete response and partial response according to the Response Evaluation Criteria in Solid Tumors version 1.1
6 months
Secondary Outcomes (1)
Adverse events
6 months
Study Arms (2)
Hepatocellular carcinoma
Hepatocellular carcinoma patients treated with nivolumab
Biliary Tract Cancer
Biliary tract cancer patients treated with pembrolizumab
Interventions
Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks
Eligibility Criteria
Hepatobiliary cancer patients treated with nivolumab or pembrolizumab
You may qualify if:
- Biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) or hepatocellular carcinoma
- Planned immune checkpoint inhibitors including nivolumab or pembrolizumab
- Written informed consent
You may not qualify if:
- Not available for the treatment with immune checkpoint inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhoon Yoo
Seoul, 05505, South Korea
Related Publications (1)
Chuah S, Lee J, Song Y, Kim HD, Wasser M, Kaya NA, Bang K, Lee YJ, Jeon SH, Suthen S, A'Azman S, Gien G, Lim CJ, Chua C, Hazirah SN, Lee HK, Lim JQ, Lim TKH, Yeong J, Chen J, Shin EC, Albani S, Zhai W, Yoo C, Liu H, Choo SP, Tai D, Chew V. Uncoupling immune trajectories of response and adverse events from anti-PD-1 immunotherapy in hepatocellular carcinoma. J Hepatol. 2022 Sep;77(3):683-694. doi: 10.1016/j.jhep.2022.03.039. Epub 2022 Apr 15.
PMID: 35430299DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changhoon Yoo, MD
Asan Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 4, 2018
Study Start
July 1, 2018
Primary Completion
July 30, 2025
Study Completion (Estimated)
July 30, 2026
Last Updated
January 28, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share