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

NCT07368530 | Completed DMC

• 1 other identifier: [2026]023
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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

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

Secondary Outcomes (2)

• Progression free survival

  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

  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

Study Arms (2)

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

Transarterial chemoembolization (TACE) PROCEDURE

1

TACE group

hepatic arterial infusion chemotherapy (HAIC) PROCEDURE

1

HAIC group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable HCC who TACE or HAIC

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiiated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: January 1, 2015
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)