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

NCT07581769 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Hepatocellular Carcinoma (HCC)
  • Downstaging
  • Liver Resection
  • Lenvatinib
  • PD1 Antibody
  • Transarterial Chemoembolization

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.

Sponsors & Collaborators

  • Zhujiang Hospital

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Wenzhe Fan, Dr. · First Affiliated Hospital, Sun Yat-Sen University

  • Shunjun Fu, Dr. · Southern Medical University, China

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07581769 on ClinicalTrials.gov