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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Unresectable Hepatocellular Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Unresectable Hepatocellular Carcinoma Patients Receiving Lenvatinib-based Therapy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Lenvatinib-based therapy
Non-lenvatinib therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	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	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	Up to 12 months after treatment initiation
Incidence of Adverse Events (AEs) and Surgical Complications	Adverse Events and surgical complications	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)

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: bc20254383

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No