Long-Term Survival With Lenvatinib-Based Therapy in Unres... | NCT07298538

Studies
Long-Term Survival With Lenvatinib-Based Therapy in Unresectable Liver Cancer

NCT07298538

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Active, not recruiting

Last Update Posted

Dec 23, 2025Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Unresectable Hepatocellular Carcinoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Nov 25, 2025

First Submission Date that Met QC Criteria

Dec 22, 2025

First Posted Date

Dec 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-year Overall Survival Rate Estimated by Kaplan-Meier Method	3-year cumulative survival rate estimated based on the Kaplan-Meier method	3 years after treatment initiation

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	The time interval from treatment initiation to the date of death due to any cause	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Unresectable Hepatocellular Carcinoma Patients Receiving Lenvatinib-based Therapy

Sampling Method

Non-Probability Sample

Label	Type	Description	Intervention Names
Lenvatinib-based therapy
Non-lenvatinib therapy