Tokyo, Sept. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063008) titled 'A Multicenter Retrospective Observational Study of Unresectable Hepatocellular Carcinoma Treated with Lenvatinib-Pretreated Transarterial Chemoembolization (LEN-TACE)' on Sept. 21.

Study Type: Observational

Primary Sponsor: Institute - Kurume University

Condition: Condition - Unresectable Hepatocellular Carcinoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To conduct a multicenter, retrospective observational study of patients with unresectable HCC who underwent LEN-TACE therapy, with the aim of elucidating its efficacy, safety, and prognostic factors in real-world clinical practice. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Patients diagnosed with histologically or clinically unresectable hepatocellular carcinoma (2) Patients who began prior LEN administration between January 1, 2019, and December 31, 2025 (3) Patients who underwent TACE within 4 weeks of starting LEN administration (4) Patients whose hepatocellular carcinoma meets the criteria of tumor diameter of 10 cm or less and no more than 10 tumors (5) Patients who have not received systemic therapy (including combination immunotherapy) or transarterial chemoembolization (TACE) prior to LEN-TACE (6) Patients who have undergone TACE no more than twice prior to LEN-TACE (7) Patients who have provided written informed consent via the informed consent form, or who have not expressed a desire to opt out of the study via the disclosure document Key exclusion criteria - (1) Patients who have undergone systemic drug therapy for other malignant tumors within the past 5 years (2) Patients participating in a clinical trial involving an intervention at the time of case registration (this does not apply to observational studies without an intervention) (3) Patients deemed ineligible for participation in this study by the principal investigator or the attending physician Target Size - 150

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 09 Month 01 Day Date of IRB - 2026 Year 09 Month 01 Day Anticipated trial start date - 2026 Year 09 Month 03 Day Last follow-up date - 2031 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072134

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