Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07581769

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Downstaging Lenvatinib Liver Diseases Liver Neoplasms Liver Resection Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial PD1 Antibody Transarterial Chemoembolization

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiiated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria;
  • Barcelona Clinic Liver Cancer (BCLC) stage B or C, assessed as unresectable by surgical evaluation; Underwent treatment with TACE combined with lenvatinib and a PD-1 inhibitor, after which the tumor was re-evaluated and deemed resectable by surgical assessment;
  • Following the achievement of surgical resectability criteria, patients subsequently underwent either R0 surgical resection or continued treatment with TACE combined with lenvatinib and a PD-1 inhibitor;
  • Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment;
  • Performance status (PS) score of 0 or 1.

Exclusion criteria

  • Patients with unclear diagnoses or those with concurrent other malignancies.
  • For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively.
  • For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors.
  • Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy.
  • Patients with severe infections, such as respiratory, biliary tract, or abdominal infections.
  • Patients with severe underlying diseases, particularly immune-related disorders.

Treatment and study plan

liver resection

Procedure

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.

TACE plus Lenvatinib and PD1 inhibiter

Procedure

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.

Primary outcomes

  1. Recurrence free survival

    Time frame: From date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months

    Time interval from date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months

Secondary outcomes

  1. Overall survival

    Time frame: From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months

    Time interval from date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • Zhujiang Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.