A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events [SAEs], grade 3 to 5 adverse events [AEs], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.

Official Title
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A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Drug: Lenvatinib
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with advanced or unresectable HCC for whom a decision has been made by the treating physician (at their discretion) to initiate lenvatinib or sorafenib treatment, within the prescribing conditions of the approved product label Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib Exclusion Criteria: None

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 |
| --- | --- |
| Lenvatinib<br>Participants with advanced or unresectable HCC will initiate treatment with lenvatinib capsules based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first. | Drug: Lenvatinib<br>* Oral capsules.<br>* Other names: E7080;|
| Sorafenib<br>Participants with advanced or unresectable HCC will initiate treatment with sorafenib tablets based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first. | Drug: Sorafenib<br>* Oral tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib |  | Up to 7 years | 
| Number of Participants With SAEs With Lenvatinib |  | Up to 7 years | 
| Number of Participants With Grade 3 to 5 AEs With Lenvatinib | AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with lenvatinib. AEs will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs. | Up to 7 years | 
| Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib | Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib will be collected at the discretion of the treating physician and in accordance with the prescribing information. | Up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Lenvatinib and Sorafenib Treatment |  | Up to 7 years | 
| Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib |  | Up to 7 years | 
| Relative Dose Intensity of Lenvatinib and Sorafenib | Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen. | Up to 7 years | 
| Overall Survival (OS) For Lenvatinib and Sorafenib | OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause. | Up to 7 years | 
| Number of Participants With Dose Interruption and Dose Reduction for Sorafenib |  | Up to 7 years | 
| Number of Participants With Hepatotoxicity TEAEs With Sorafenib |  | Up to 7 years | 
| Number of Participants With SAEs With Sorafenib |  | Up to 7 years | 
| Number of Participants With Grade 3 to 5 AEs With Sorafenib | AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with sorafenib. AEs will be graded using NCI CTCAE. Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs. | Up to 7 years | 
| Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib | Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib will be collected at the discretion of the treating physician and in accordance with the prescribing information. | Up to 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lenvatinib, Advanced or unresectable carcinoma hepatocellular, E7080