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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Changhoon Yoo，Asan Medical Center

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

July 1, 2018

Estimated Primary Completion Date

July 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational [Patient Registry]

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational [Patient Registry]
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

: Hepatocellular carcinoma
Hepatocellular carcinoma patients treated with nivolumab
: Biliary Tract Cancer
Biliary tract cancer patients treated with pembrolizumab

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2021

Estimated Primary Completion Date

July 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

19 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Changhoon Yoo，Asan Medical Center

Study Sponsor ^ICMJE

Asan Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Changhoon Yoo, MD Asan Medical Center

PRS Account

Asan Medical Center

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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