Radiomics Subtyping to Guide Surgery vs. Maintenance Therapy After HCC Downstaging

The goal of this observational study is to learn about the long-term treatment outcomes for patients with initially unresectable hepatocellular carcinoma (HCC) who achieve successful downstaging with the combination therapy of TACE, lenvatinib, and a PD-1 inhibitor. The main questions it aims to answer are: Can distinct disease subtypes be identified in successfully downstaged patients using radiomics and clinical data? Do these different subtypes show significant differences in long-term outcomes, such as recurrence-free survival and overall survival, after undergoing either curative-intent surgical resection or continuing maintenance therapy? Based on the identified subtypes, can the investigators objectively determine which patients are more suitable for surgical resection and which patients may benefit more from continued maintenance therapy after successful downstaging? The study will include patients who have already undergone the combination therapy as part of their regular medical care, successfully achieved tumor downstaging (making the tumor technically resectable), and subsequently received either surgical resection or continued maintenance treatment. Researchers will retrospectively analyze their existing clinical and imaging data to compare long-term outcomes between these two treatment paths based on their identified disease subtype.

NCT Number	NCT07581769
Lead Sponsor	First Affiliated Hospital, Sun Yat-Sen University Collaborators: Zhujiang Hospital
Conditions	Hepatocellular Carcinoma (HCC), Downstaging, Liver Resection, Lenvatinib, PD1 Antibody, Transarterial Chemoembolization
Enrollment	500 participants
Start Date	2018-01-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-14