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Completed

NCT Number: NCT07368530

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

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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Key information

Conditions

Unresectable Hepatocellular Carcinoma (HCC) Adenocarcinoma BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

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, 510080, China

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;
  • Received either TACE or HAIC as the sole interventional treatment modality throughout the treatment course (no crossover between the two modalities allowed);
  • 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 an unclear diagnosis or those with concurrent other malignant tumors;
  • Liver function classified as Child-Pugh Class C or worse, which cannot be improved after hepatoprotective treatment;
  • Patients with severe infections, such as respiratory, biliary tract, or abdominal infections;
  • Patients with severe underlying diseases, particularly immune-related disorders.
  • Patients with severely incomplete or missing baseline or outcome data.

Treatment and study plan

Transarterial chemoembolization (TACE)

Procedure

1

hepatic arterial infusion chemotherapy (HAIC)

Procedure

1

Primary 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2026
Registry last updated
Jan 26, 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.

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