Biliary Tract Cancer, Hepatocellular Carcinoma
Conditions
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.
Interventions
Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks
Sponsors
Asan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 6 months | Toxicity of nivolumab or pembrolizumab according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 |
Countries
South Korea
Outcome results
None listed