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

NCT ID: NCT07298538

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Unresectable Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lenvatinib-based therapy

No interventions assigned to this group

Non-lenvatinib therapy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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bc20254383

Identifier Type: -

Identifier Source: org_study_id