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

• Conditions: Biliary Tract Cancer; Hepatocellular Carcinoma
• Interventions: Drug: Nivolumab or pembrolizumab

• Registration Number: NCT03695952
• Lead Sponsor: Asan Medical Center

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.

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 Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22
• Primary Completion: 2023-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Not available for the treatment with immune checkpoint inhibitors

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatocellular carcinoma	Nivolumab or pembrolizumab	Hepatocellular carcinoma patients treated with nivolumab
Biliary Tract Cancer	Nivolumab or pembrolizumab	Biliary tract cancer patients treated with pembrolizumab

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events	6 months	Toxicity of nivolumab or pembrolizumab according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

Trial Locations

Locations (1)

Changhoon Yoo; 🇰🇷 Seoul, Korea, Republic of