Carcinoma, Hepatocellular
Conditions
Keywords
Lenvatinib, Advanced or unresectable carcinoma hepatocellular, E7080
Brief summary
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.
Interventions
DRUGLenvatinib
Oral capsules.
DRUGSorafenib
Oral tablets.
Sponsors
Eisai Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 7 years | 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. |
| Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib | Up to 7 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Dose Interruption and Dose Reduction for Lenvatinib | Up to 7 years | — |
| Number of Participants With Grade 3 to 5 AEs With Sorafenib | Up to 7 years | 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. |
| Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib | Up to 7 years | 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. |
| Number of Participants With SAEs With Sorafenib | Up to 7 years | — |
| Duration of Lenvatinib and Sorafenib Treatment | Up to 7 years | — |
| Relative Dose Intensity of Lenvatinib and Sorafenib | Up to 7 years | Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen. |
| Overall Survival (OS) For Lenvatinib and Sorafenib | Up to 7 years | OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause. |
Countries
Australia, Austria, Germany, Italy, Portugal, Russia, Spain, Sweden, United Kingdom, United States
Outcome results
None listed