Carcinoma, HepatocellularNCT07849660
Real-World Lenvatinib Sequencing in Unresectable Hepatocellular Carcinoma (uHCC)
An observational study of Carcinoma, Hepatocellular, run by Eisai Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Lenvatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Real-World Sequencing Outcomes in Unresectable Hepatocellular Carcinoma (uHCC)
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
- Being tested
- Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called Lenvima
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)
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib Cohort A | Not described Receives: Drug: Lenvatinib | |
| Lenvatinib Cohort B | Not described Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A Overall Survival (OS)
Retrospectively evaluate the effectiveness of 1L Lenvatinib in a real-world setting
Measured: 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
Measured: 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
Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Measured: 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)
Proportion of patients with a best response to Lenvatinib therapy of CR or PR
Measured: 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)
Proportion of patients with a best response to Lenvatinib therapy of CR, PR, or SD
Measured: 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)
Proportion of patients with a best response to Lenvatinib therapy of CR, PR, or durable SD (duration of stable disease ≥23 weeks)
Measured: 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)
Time from the date of Lenvatinib initiation until the date of first documented progression or death (whichever occurs first)
Measured: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Progression Free Survival Post-Progression (PFS2)
Time from the date of Lenvatinib initiation until the date of disease progression on the next-line treatment or death from any cause (whichever occurs first)
Measured: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Time to Next Treatment (TTNT) from Lenvatinib Initiation
Time from the date of Lenvatinib initiation until the date of start of next treatment
Measured: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Treatment Patterns in uHCC Patients that received Lenvatinib
Treatment patterns will include time to Lenvatinib discontinuation, duration of Lenvatinib treatment, Lenvatinib dose intensity, reasons for Lenvatinib discontinuation, percentage with and time to first Lenvatinib dose reduction, and proportion with and time to surgical resection and transplantation after Lenvatinib initiation
Measured: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Relational Sequencing of All Treatment Regimens received for uHCC
Relational sequencing will include 1L and 2L Lenvatinib, 1L immunotherapy (for Cohort B), and all subsequent treatment lines after Lenvatinib discontinuation
Measured: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start17 Nov 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849660
- Sponsor's protocol ID
- R7000-M001-009
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Real-World Sequencing Outcomes in Unresectable Hepatocellular Carcinoma (uHCC)
- ClinicalTrials.gov ID
- NCT07849660
- Acronym / sponsor ID
- R7000-M001-009
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib Cohort A | – | Drug: Lenvatinib |
| Lenvatinib Cohort B | – | Drug: Lenvatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Diagnosed with uHCC, as confirmed by radiology, histology, or cytology
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibAlso: Lenvima12 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) | Drug | Lenvatinib Cohort A, Lenvatinib Cohort B |
Primary outcome
Cohort A Overall Survival (OS)
Time frame: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Retrospectively evaluate the effectiveness of 1L Lenvatinib in a real-world setting
Cohort B OS
Time frame: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Retrospectively evaluate the effectiveness of 2L Lenvatinib
9 secondary outcomes
Best Clinical Response to Lenvatinib Therapy
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Progression Free Survival Post-Progression (PFS2)
Time frame: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Time to Next Treatment (TTNT) from Lenvatinib Initiation
Time frame: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Treatment Patterns in uHCC Patients that received Lenvatinib
Time frame: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Relational Sequencing of All Treatment Regimens received for uHCC
Time frame: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Eisai Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A Overall Survival (OS) (time frame: From initiation of Lenvatinib therapy until date of death or until last available follow-up before data extraction (approximately 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.