NCT07849660Active, not recruiting
Real-World Lenvatinib Sequencing in Unresectable Hepatocellular Carcinoma (uHCC)
Understanding Real-World Sequencing Outcomes in Unresectable Hepatocellular Carcinoma (uHCC)
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 170 (actual)
- First submitted
- 24 Sept 2026
- Start date
- 17 Nov 2025
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- Eisai Inc.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07849660
What you commit to
- Study type: Observational
- Participants enrolled: 170
- From 17 Nov 2025 to the primary completion date, 15 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Esophageal or gastric variceal bleeding within 6 months before the index date
- 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
Other illness
- 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
Other
- Vp4 at Lenvatinib initiation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Nutley | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.