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

Tianjin Medical University

Status: Active, not recruiting

Conditions: Unresectable Hepatocellular Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT07298538

bc20254383

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

800 participants in 2 patient groups

Lenvatinib-based therapy

Non-lenvatinib therapy