Clinical trial · Observational
Real-World Lenvatinib Sequencing in Unresectable Hepatocellular Carcinoma (uHCC)
Understanding Real-World Sequencing Outcomes in Unresectable Hepatocellular Carcinoma (uHCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Oct 1, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20261001-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Lenvatinib Cohort A
- interventionNames
- Drug: Lenvatinib
- label
- Lenvatinib Cohort B
- interventionNames
- Drug: Lenvatinib
Primary outcomes (2)
- measure
- Cohort A Overall Survival (OS)
- timeFrame
- From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
- description
- Retrospectively evaluate the effectiveness of 1L Lenvatinib in a real-world setting
- measure
- Cohort B OS
- timeFrame
- From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available