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CompletedNCT07368530Updated Jan 26, 2026

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

An observational study in Unresectable Hepatocellular Carcinoma (HCC), BCLC Stage B Hepatocellular Carcinoma and BCLC Stage C Hepatocellular Carcinoma, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,000
Ages
18 Years to 75 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Unresectable Hepatocellular Carcinoma (HCC)
  • BCLC Stage B Hepatocellular Carcinoma
  • BCLC Stage C Hepatocellular Carcinoma

Keywords

  • hepatocellular carcinoma
  • transarterial chemoembolization
  • hepatic arterial infusion chemotherapy
  • machine learning
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In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's enrollment of 3,000 is above the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with unresectable HCC who TACE or HAIC

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,000 participants (actual)
Patient registry
No

Groups and cohorts

  • TACE group

    Patients with unresectable HCC treated with transarterial chemoembolization

    Procedure: Transarterial chemoembolization (TACE)

  • HAIC group

    Patients with unresectable HCC treated with hepatic arterial infusion chemotherapy

    Procedure: hepatic arterial infusion chemotherapy (HAIC)

Interventions

  • ProcedureTransarterial chemoembolization (TACE)

    1

  • Procedurehepatic arterial infusion chemotherapy (HAIC)

    1

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What researchers measure

Primary outcomes

  1. Overall survival

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

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

Secondary outcomes

  1. Progression free survival

    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

    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

  2. Tumor response

    Defined as the proportion of patients achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) according to mRECIST criteria.

    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

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Study locations

1 site
  • The First Affiiated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
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References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07368530
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible party
Wenzhe Fan (Professor, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Jan 26, 2026
Start date
Jan 1, 2015
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Jan 26, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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