Unresectable Hepatocellular CarcinomaNCT07298538
Long-Term Survival With Lenvatinib-Based Therapy in Unresectable Liver Cancer
An observational study of Unresectable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study reviewed real-world outcomes of patients with unresectable hepatocellular carcinoma who received lenvatinib-based treatment. The study evaluated long-term survival, treatment response, and safety using data collected from six hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to Dec 2027
- 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: Unresectable Hepatocellular Carcinoma Patients Receiving Lenvatinib-based Therapy
Who may be able to join
- ≥ 18 years of age
- Patients with histologically or radiologically confirmed HCC who were newly diagnosed between January 2019 and December 2022 (meeting the diagnostic criteria of the American Association for the Study of Liver Diseases or the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer).
- Patients with at least 1 measurable lesion in the liver per RECIST v.1.1.
- Initially unresectable HCC as determined by the investigator (including oncologically unresectable, surgically unresectable, or both).
- Child Pugh score ≤ 7
- ECOG-PS 0-1
- Patients who had not received any previous systemic therapy before receiving dual therapy (lenvatinib + immunotherapy/local therapy) or triple therapy (lenvatinib + immunotherapy + local therapy) as the first-line therapy. Combination therapy is defined as the initiation of immunotherapy or local therapy within 30 days (before or after) of the first dose of lenvatinib.
- Patients who had basic image data (CT/MRI/PET) and underwent at least one imaging evaluation during the systemic therapy (if the image data was obtained from other hospitals, the original data shall be provided for re-evaluation).
Who cannot join
- Patients with no overall survival (OS) endpoint observed, and a follow-up period after treatment initiation of less than 6 months.
- Patients with a pathological diagnosis of combined hepatocellular and intrahepatic cholangiocarcinoma (cHCC-ICC), cholangiocarcinoma, or other non-HCC malignant tumors.
- Patients with other inadequately treated malignant tumors previously or currently.
- Prior liver transplantation/hepatectomy/ablation for liver cancer.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
About this study
Official title: Long-term Survival of Unresectable Hepatocellular Carcinoma Patients Receiving Lenvatinib-based Therapy: A Retrospective, Multicenter Propensity Score Matching Study
This study reviewed real-world outcomes of patients with unresectable hepatocellular carcinoma who received lenvatinib-based treatment. The study evaluated long-term survival, treatment response, and safety using data collected from six hospitals.
- Conditions
- Unresectable Hepatocellular Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib-based therapy | Not described | |
| Non-lenvatinib therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Overall Survival Rate Estimated by Kaplan-Meier Method
3-year cumulative survival rate estimated based on the Kaplan-Meier method
Measured: 3 years after treatment initiation
Secondary outcomes (5)
Overall survival (OS)
The time interval from treatment initiation to the date of death due to any cause
Measured: Up to 5 years after treatment initiation
Event-free survival (EFS)
The time interval from treatment initiation to the occurrence of any event, including disease progression, recurrence (surgical patients), discontinuation of treatment for any reason, or death. EFS is assessed by RECIST v1.1.
Measured: Up to 5 years after treatment initiation
4-year and 5-year OS rates
4-year and 5-year cumulative survival rates estimated based on the Kaplan-Meier method
Measured: 4 years and 5 years after treatment initiation
Objective response rate (ORR)
The proportion of patients who achieved the best overall response (BOR) of complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1
Measured: Up to 12 months after treatment initiation
Incidence of Adverse Events (AEs) and Surgical Complications
Adverse Events and surgical complications
Measured: AEs: from treatment initiation through 30 days after last dose of lenvatinib-based therapy; Surgical complications: perioperative period (day of surgery through 30 days post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jan 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298538
- Sponsor's protocol ID
- bc20254383
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Survival of Unresectable Hepatocellular Carcinoma Patients Receiving Lenvatinib-based Therapy: A Retrospective, Multicenter Propensity Score Matching Study
- ClinicalTrials.gov ID
- NCT07298538
- Acronym / sponsor ID
- bc20254383
- Conditions
- Unresectable Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Dec 2025 (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 study reviewed real-world outcomes of patients with unresectable hepatocellular carcinoma who received lenvatinib-based treatment. The study evaluated long-term survival, treatment response, and safety using data collected from six hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib-based therapy | – | – |
| Non-lenvatinib therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresectable Hepatocellular Carcinoma Patients Receiving Lenvatinib-based Therapy
Key inclusion criteria (8 listed)
- ≥ 18 years of age
- Patients with histologically or radiologically confirmed HCC who were newly diagnosed between January 2019 and December 2022 (meeting the diagnostic criteria of the American Association for the Study of Liver Diseases or the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer).
- Patients with at least 1 measurable lesion in the liver per RECIST v.1.1.
- Initially unresectable HCC as determined by the investigator (including oncologically unresectable, surgically unresectable, or both).
- Child Pugh score ≤ 7
Key exclusion criteria (4 listed)
- Patients with no overall survival (OS) endpoint observed, and a follow-up period after treatment initiation of less than 6 months.
- Patients with a pathological diagnosis of combined hepatocellular and intrahepatic cholangiocarcinoma (cHCC-ICC), cholangiocarcinoma, or other non-HCC malignant tumors.
- Patients with other inadequately treated malignant tumors previously or currently.
- Prior liver transplantation/hepatectomy/ablation for liver cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3-year Overall Survival Rate Estimated by Kaplan-Meier Method
Time frame: 3 years after treatment initiation
3-year cumulative survival rate estimated based on the Kaplan-Meier method
5 secondary outcomes
Overall survival (OS)
Time frame: Up to 5 years after treatment initiation
Event-free survival (EFS)
Time frame: Up to 5 years after treatment initiation
4-year and 5-year OS rates
Time frame: 4 years and 5 years after treatment initiation
Objective response rate (ORR)
Time frame: Up to 12 months after treatment initiation
Incidence of Adverse Events (AEs) and Surgical Complications
Time frame: AEs: from treatment initiation through 30 days after last dose of lenvatinib-based therapy; Surgical complications: perioperative period (day of surgery through 30 days post-surgery)
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 23 Dec 2025.
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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 Unresectable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 8 inclusion and 4 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 23 Dec 2025. 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 China. 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?
3-year Overall Survival Rate Estimated by Kaplan-Meier Method (time frame: 3 years after treatment initiation). 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 23 Dec 2025.