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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695952
• Other study ID #: ICI_Biomarker
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: July 2024

Study information

• Verified date: July 2021
• Source: Asan Medical Center
• Contact: Changhoon Yoo, MD
• Phone: +82230101727
• Email: yooc[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Nivolumab or pembrolizumab
Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Changhoon Yoo	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	Toxicity of nivolumab or pembrolizumab according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03	6 months