CompletedNot Applicable

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

United States, Australia335 participantsStarted 2021-04-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib

Timeframe: Up to 7 years

Number of Participants With SAEs With Lenvatinib

Timeframe: Up to 7 years

Number of Participants With Grade 3 to 5 AEs With Lenvatinib

Timeframe: Up to 7 years

Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib

Timeframe: Up to 7 years

Trial details

NCT IDNCT04763408

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-13

View on ClinicalTrials.gov More Carcinoma, Hepatocellular trials