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

NCT07298538 | Active Not Recruiting

• 1 other identifier: bc20254383
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• Overall survival (OS)

  Up to 5 years after treatment initiation

• Event-free survival (EFS)

  Up to 5 years after treatment initiation

• 4-year and 5-year OS rates

  4 years and 5 years after treatment initiation

• Objective response rate (ORR)

  Up to 12 months after treatment initiation

• Incidence of Adverse Events (AEs) 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)

Study Arms (2)

Lenvatinib-based therapy

Non-lenvatinib therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unresectable Hepatocellular Carcinoma Patients Receiving Lenvatinib-based Therapy

You may qualify if:

• ≥ 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-11

Locations

CN (1)