Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Clovis, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Carcinoma, Hepatocellular Lenvatinib Advanced or unresectable carcinoma hepatocellular E7080 Carcinoma Sorafenib

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

None

Locations

  • UCSF Fresno in progress, not accepting new patients
    Clovis California 93701 United States
  • California Liver Research Institute accepting new patients
    Pasadena California 91105 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eisai Inc.
ID
NCT04763408
Study Type
Observational
Participants
Expecting 1000 study participants
Last Updated