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

Sponsor
Asan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03695952
Collaborator
(none)
100
Enrollment
1
Location
72
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nivolumab or pembrolizumab

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Cohort Study of Patients With Hepatobiliary Cancer Treated With Immune Checkpoint Inhibitors
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Hepatocellular carcinoma

Hepatocellular carcinoma patients treated with nivolumab

Drug: Nivolumab or pembrolizumab
Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks
Other Names:
  • Immune checkpoint inhibitors

    		•
    Biliary Tract Cancer

    Biliary tract cancer patients treated with pembrolizumab

    Drug: Nivolumab or pembrolizumab
    Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks
    Other Names:
  • Immune checkpoint inhibitors

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate [6 months]

      Proportion of complete response and partial response according to the Response Evaluation Criteria in Solid Tumors version 1.1

    Secondary Outcome Measures

    1. Adverse events [6 months]

      Toxicity of nivolumab or pembrolizumab according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Changhoon Yoo Seoul Korea, Republic of 05505

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    • Principal Investigator: Changhoon Yoo, MD, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Changhoon Yoo, Assistant Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT03695952
    Other Study ID Numbers:
    • ICI_Biomarker
    First Posted:
    Oct 4, 2018
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Biliary Tract Neoplasms
    Pembrolizumab
    Nivolumab
    Immune Checkpoint Inhibitors

    Study Results

    No Results Posted as of Jul 22, 2021