A Study to Assess Overall Survival and Treatment Patterns for Advanced Liver Cancer Participants Who Received Nivolumab Therapy

Study Overview
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Brief Summary
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A study to describe real-world treatment patterns and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy

Detailed Description
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The central aims of this study are descriptive and designed to describe the patient demographics, clinical characteristics, treatment patterns, and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy in the real-world setting.

Official Title
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Overall Survival and Treatment Patterns for Advanced Hepatocellular Carcinoma Patients Who Received Second or Third Line Nivolumab Therapy

Conditions
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Hepatocellular Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult aHCC participants in the Flatiron database as defined by: Diagnosed with HCC International Classification of Diseases (ICD)-9 155.x or ICD-10 C22.x) Pathology consistent with advanced HCC Age 18 years or older at index At least two clinic encounters on different days in the Flatiron database occurring on or after January 1, 2011 Participants who received second or third line nivolumab monotherapy or combination therapy for aHCC Exclusion Criteria: Participants with <1 month of medical data (any clinic visits, medication administrations or oral medication prescriptions) following and including the index date Participants with clinical study drug during prior or post study index periods Other protocol-defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced Hepatocellular Carcinoma (aHCC) cohort<br>aHCC cohort selected from the Flatiron Health Oncology electronic health record (EHR) data from January 2011 to the most recent data available. The index date will be defined as the start of second or third line nivolumab therapy for aHCC between January 1, 2011 and the most recent data available. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment patterns | Nivolumab second and third lines of therapy will be described including prior lines of therapy, duration of nivolumab therapy and time from aHCC diagnosis date to first nivolumab treatment | From aHCC diagnosis date to first nivolumab treatment (Up to 7.75 years) | 
| Overall Survival | The initial second or third line nivolumab therapy date will be used as the start date for the OS analysis. Occurrence of death will be considered as event and the duration for event will be calculated as time from 2L or 3L nivolumab therapy date to death date. Patients who survived will be censored and their duration period will be the time between the initial 2L or 3L nivolumab therapy date and the last date of their post-period follow up | From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years) |