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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma, Biliary Tract Cancer

Intervention / Treatment
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* Drug: Nivolumab or pembrolizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatocellular carcinoma<br>Hepatocellular carcinoma patients treated with nivolumab | Drug: Nivolumab or pembrolizumab<br>* Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks<br>* Other names: Immune checkpoint inhibitors;|
| Biliary Tract Cancer<br>Biliary tract cancer patients treated with pembrolizumab | Drug: Nivolumab or pembrolizumab<br>* Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks<br>* Other names: Immune checkpoint inhibitors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Toxicity of nivolumab or pembrolizumab according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 | 6 months |