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NCT07581769

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

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

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.

Official title: A Retrospective Radiomics-Based Subtyping Study to Guide Post-Downstaging Treatment Selection in Patients With Unresectable Hepatocellular Carcinoma Following TACE Plus Lenvatinib and Anti PD-1

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2018-01-01

Completion Date

2026-12-31

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

PROCEDURE

Liver resection

This intervention consists of curative-intent surgical resection of hepatocellular carcinoma (HCC) performed after successful downstaging achieved through prior TACE combined with lenvatinib and PD-1 inhibitor therapy. The procedure aims to remove all visible and radiologically responsive tumor tissue to achieve a pathologically confirmed R0 resection margin.

PROCEDURE

TACE plus Lenvatinib and PD1 inhibiter

This intervention describes the non-surgical maintenance therapy for patients in the Maintenance Group after successful downstaging. It consists of continuing the same doses of lenvatinib and PD-1 inhibitor that were administered during the downstaging phase, combined with on-demand TACE performed only upon imaging or biomarker evidence of intrahepatic progression.

Locations (2)

The First Affiiated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China