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

NCT07849660 | Active Not Recruiting

• 1 other identifier: R7000-M001-009
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will use existing real-world data from routine clinical care to describe patients with uHCC who received lenvatinib. The study will include two groups: patients who started lenvatinib as first-line (1L) treatment and patients who started lenvatinib as second-line (2L) treatment after prior 1L immunotherapy was stopped because the cancer progressed or because of toxicity. All study information will be collected retrospectively from existing patient records. Patients will be followed from the start of lenvatinib until death or their last documented follow-up before data extraction. The primary objectives of this study are:

• To retrospectively evaluate the effectiveness of 1L lenvatinib in a real-world setting as measured by overall survival (OS)
• To retrospectively evaluate the effectiveness of 2L lenvatinib as measured by OS after progression on or discontinuation of prior 1L immunotherapy
• 1L immunotherapies to be considered include atezolizumab plus bevacizumab (Atezo/Bev) or durvalumab plus tremelimumab (Durva/Treme) combination therapies, based on preferred regimens listed by National Comprehensive Cancer Network (NCCN) 2025 guidelines

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (2)

• Cohort A Overall Survival (OS)

  Retrospectively evaluate the effectiveness of 1L Lenvatinib in a real-world setting

  From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)

• Cohort B OS

  Retrospectively evaluate the effectiveness of 2L Lenvatinib

  From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)

Secondary Outcomes (9)

• Best Clinical Response to Lenvatinib Therapy

  From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)

• Overall Response Rate (ORR)

  From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)

• Disease Control Rate (DCR)

  From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)

• Clinical Benefit Rate (CBR)

  From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)

• Progression Free Survival (PFS)

  From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)

Study Arms (2)

Lenvatinib Cohort A

Drug: Lenvatinib

Lenvatinib Cohort B

Drug: Lenvatinib

Interventions

Lenvatinib DRUG

12 milligram (mg) based on the participant's body weight greater than or equal to (≥) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (\<) 60 kg at baseline, orally, once daily (QD)

Also known as: Lenvima

Lenvatinib Cohort A; Lenvatinib Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in both Cohorts must be adults with uHCC not amenable to locoregional therapy (LRT), diagnosed from 01 Sept 2020 to 30 Sept 2023, and confirmed by radiology, histology, or cytology. They will be excluded for main portal vein invasion (Vp4), esophageal or gastric variceal bleeding within 6 months before the index date, concurrent malignancy requiring active treatment (except non-melanoma skin cancer or curatively treated in situ cervical cancer), or prior liver transplant. Cohort A patients must have started 1L lenvatinib at the FDA-approved dose and have BCLC Stage B/C disease, ECOG performance status 0/1, and Child-Pugh A (score 5/6) liver function. Cohort B patients must have received 1L atezolizumab plus bevacizumab or durvalumab plus tremelimumab, then progressed or discontinued due to toxicity, with BCLC Stage B/C disease, ECOG performance status 0/1, and Child-Pugh A (score 5/6) or B (score 7) liver function.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Eisai Trial Site #1

Nutley, New Jersey, 07110, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: November 17, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)