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OpenTrials
Active, Not Recruiting

NCT Number: NCT03695952

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhoon Yoo

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nivolumab or pembrolizumab

Drug

Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks

Other names: Immune checkpoint inhibitors

Primary outcomes

  1. Objective response rate

    Time frame: 6 months

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

Secondary outcomes

  1. Adverse events

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Oct 4, 2018
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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