Unresectable Hepatocellular Carcinoma
Conditions
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.
Interventions
None listed
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.1.1. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Overall Survival Rate Estimated by Kaplan-Meier Method | 3 years after treatment initiation | 3-year cumulative survival rate estimated based on the Kaplan-Meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | Up to 5 years after treatment initiation | 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. |
| 4-year and 5-year OS rates | 4 years and 5 years after treatment initiation | 4-year and 5-year cumulative survival rates estimated based on the Kaplan-Meier method |
| Overall survival (OS) | Up to 5 years after treatment initiation | The time interval from treatment initiation to the date of death due to any cause |
| Objective response rate (ORR) | Up to 12 months after treatment initiation | 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 |
| 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) | Adverse Events and surgical complications |
Countries
China
Outcome results
None listed