NCT07298538
Active, not recruiting
Not Applicable
Long-term Survival of Unresectable Hepatocellular Carcinoma Patients Receiving Lenvatinib-based Therapy: A Retrospective, Multicenter Propensity Score Matching Study
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country800 target enrollmentStarted: January 1, 2019Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- 3-year Overall Survival Rate Estimated by Kaplan-Meier Method
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Outcomes
Primary Outcomes
3-year Overall Survival Rate Estimated by Kaplan-Meier Method
Time Frame: 3 years after treatment initiation
3-year cumulative survival rate estimated based on the Kaplan-Meier method
Secondary Outcomes
- 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))
Investigators
Study Sites (1)
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