Unresectable Hepatocellular Carcinoma (HCC)NCT07368530
Using Machine Learning to Identify Responders to TACE or HAIC for uHCC
An observational study of Unresectable Hepatocellular Carcinoma (HCC) and BCLC Stage B Hepatocellular Carcinoma, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma (HCC), BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma
- What is being tested?
- Transarterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unresectable HCC who TACE or HAIC
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiiated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official 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
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?
Read more
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
- Being tested
- Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC)
- Keywords
- hepatocellular carcinoma, transarterial chemoembolization, hepatic arterial infusion chemotherapy, machine learning
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial chemoembolization (TACE)Procedure or surgery
1
hepatic arterial infusion chemotherapy (HAIC)Procedure or surgery
1
| Study group | Role | What they receive |
|---|---|---|
| TACE group | Patients with unresectable HCC treated with transarterial chemoembolization Receives: Procedure: Transarterial chemoembolization (TACE) | |
| HAIC group | Patients with unresectable HCC treated with hepatic arterial infusion chemotherapy Receives: Procedure: hepatic arterial infusion chemotherapy (HAIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Defined as the proportion of patients achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) according to mRECIST criteria.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2015
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenzhe Fan, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368530
- Sponsor's protocol ID
- [2026]023
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07368530
- Acronym / sponsor ID
- [2026]023
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE group | – | Procedure: Transarterial chemoembolization (TACE)Patients with unresectable HCC treated with transarterial chemoembolization |
| HAIC group | – | Procedure: hepatic arterial infusion chemotherapy (HAIC)Patients with unresectable HCC treated with hepatic arterial infusion chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable HCC who TACE or HAIC
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial chemoembolization (TACE)1 | Procedure or surgery | TACE group |
| hepatic arterial infusion chemotherapy (HAIC)1 | Procedure or surgery | HAIC group |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Hepatocellular Carcinoma (HCC) and BCLC Stage B Hepatocellular Carcinoma, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.