Using Machine Learning to Identify Responders to TACE or HAIC for uHCC

January 16, 2026 updated by: Wenzhe Fan, First Affiliated Hospital, Sun Yat-Sen University

Radiomics-based Unsupervised Machine Learning Model to Identify Responders to Transarterial Chemoembolization Versus Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: a Retrospective Cohort Study

The goal of this observational study is to learn about the efficacy of Transarterial Chemoembolization (TACE) versus Hepatic Arterial Infusion Chemotherapy (HAIC) in patients with unresectable hepatocellular carcinoma (HCC). The main questions it aims to answer are:

Can distinct imaging phenotype subtypes be identified in unresectable HCC patients using radiomics and unsupervised clustering?

Do these different imaging subtypes show significant differences in treatment efficacy (such as objective response rate, progression-free survival, and overall survival) after receiving TACE or HAIC?

Can this method objectively identify which imaging subtype of patients is more suitable for TACE and which may benefit more from HAIC?

Participants in this study are adult patients diagnosed with unresectable HCC (BCLC stage B or C) who have already undergone complete TACE or HAIC treatment as part of their regular medical care between January 2015 and December 2024. Researchers will retrospectively analyze their existing clinical data and pre-treatment medical images to compare outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiiated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with unresectable HCC who TACE or HAIC

Description

Inclusion Criteria:

  1. Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria;
  2. Barcelona Clinic Liver Cancer (BCLC) stage B or C, assessed as unresectable by surgical evaluation;
  3. Received either TACE or HAIC as the sole interventional treatment modality throughout the treatment course (no crossover between the two modalities allowed);
  4. Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment;
  5. Performance status (PS) score of 0 or 1.

Exclusion Criteria:

  1. Patients with an unclear diagnosis or those with concurrent other malignant tumors;
  2. Liver function classified as Child-Pugh Class C or worse, which cannot be improved after hepatoprotective treatment;
  3. Patients with severe infections, such as respiratory, biliary tract, or abdominal infections;
  4. Patients with severe underlying diseases, particularly immune-related disorders.
  5. Patients with severely incomplete or missing baseline or outcome data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TACE group
Patients with unresectable HCC treated with transarterial chemoembolization
Procedure: Transarterial chemoembolization (TACE)
1
HAIC group
Patients with unresectable HCC treated with hepatic arterial infusion chemotherapy
Procedure: hepatic arterial infusion chemotherapy (HAIC)
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: From date of initial treatment until the date of first documented progression 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 progression or date of death from any cause, whichever came first, assessed up to 24 months
From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Tumor response
Time Frame: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Defined as the proportion of patients achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) according to mRECIST criteria.
From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2026]023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study utilizes existing clinical and imaging data collected as part of routine medical care. The dataset contains detailed and potentially re-identifiable patient information, including medical images, clinical records, and treatment outcomes. Due to institutional data privacy policies, ethical restrictions related to patient confidentiality, and the lack of broad consent from participants for data sharing beyond the scope of this specific research, we are unable to publicly share individual participant data. All data will be stored securely within the hospital's internal research database, and access will be restricted to the study investigators for analysis purposes only. Requests for aggregated or de-identified results may be considered upon reasonable inquiry to the corresponding author, subject to institutional review and compliance with applicable regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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