Real-World Lenvatinib Sequencing in Unresectable Hepatocellular Carcinoma (uHCC)

Official record

Identifier

NCT07849660

Recruiting locations

country

United States

Interventions studied

Lenvatinib

Lead sponsor

Eisai Inc.

Target enrolment

170 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Active, not recruiting

First posted

Sep 30, 2026

Last updated on the registry

Sep 30, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Diagnosed with uHCC, as confirmed by radiology, histology, or cytology

  * 18 years of age at the time of Lenvatinib initiation for uHCC
* Initiated, within standard clinical practice, 1L Lenvatinib (Cohort A) or initiated 2L Lenvatinib after progression on or discontinuation (due to toxicity) of prior immunotherapy (Cohort B) between 01 Sep 2020 and 30 Sep 2023
* BCLC Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy at initial diagnosis of metastatic uHCC
* At least one measurable target lesion at Lenvatinib initiation
* ECOG performance status 0 or 1 at Lenvatinib initiation
* If deceased, have a reported date of death.

Cohort A

* Child-Pugh A (score 5 or 6) classification of uHCC at Lenvatinib initiation
* Initiated Lenvatinib with US FDA approved starting dose (12 mg once daily for patients weighing ≥60 kg, or 8 mg once daily for patients weighing \<60 kg

Cohort B

* Patients may have either Child-Pugh A (score 5 or 6) or Child-Pugh B (score 7) classification of uHCC at Lenvatinib initiation

Exclusion Criteria:

* Vp4 at Lenvatinib initiation
* Esophageal or gastric variceal bleeding within 6 months before the index date
* Had a prior history of other malignancy that required active treatment; exceptions include non-melanoma skin cancer or in situ cervical cancer that has potentially curative therapy underwent
* History of liver transplant

Cohort A

* Received other 1L systemic therapy or LRT concurrently with Lenvatinib

Cohort B

* Received other immunotherapy not inclusive of atezolizumab plus bevacizumab or durvalumab plus tremelimumab combination therapies
* Received other 2L systemic therapy or LRT concurrently with Lenvatinib

Indexed under

Liver Cancer