Transcatheter Arterial ChemoembolizationNCT07065786
A Generative Model-based System for Predicting Survival and Guiding Treatment Decisions in Patients With Unresectable Hepatocellularcarcinoma Undergoing Transcatheter Arterial Chemoembolization in Combination With Immunotherapy and Targeted Therapy
An observational study of Transcatheter Arterial Chemoembolization and Unresectable Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
The entry point of this study is the proposition of "generative longitudinal prediction," which utilizes only pre-treatment imaging to create high-fidelity predictions of post-treatment imaging. This approach effectively overcomes the clinical challenge of acquiring genuine longitudinal follow-up data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Arterial Chemoembolization, Unresectable Hepatocellular Carcinoma
- What is being tested?
- Generative model
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Feb 2026
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unresectable hepatocellular carcinoma undergoing TACE in combination with immunotherapy plus targeted therapy
Who may be able to join
- Diagnosed as unresectable hepatocellular carcinoma (HCC) by histopathology and/or clinical diagnosis (typical imaging features, clinical manifestations, laboratory tests, etc.) (Reference: Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition));
- Patients with unresectable HCC receiving TACE combined with targeted immunotherapy;
- Liver function classified as Child-Pugh A or B;
- Aged 18 or above, regardless of gender;
- Expected survival time ≥3 months;
- ECOG PS score ≤2;
- Meeting the following laboratory parameters: a) Hematologic function: Absolute neutrophil count ≥1.0×10⁹/L; Platelet count ≥50×10⁹/L; Hemoglobin ≥90 g/L; International normalized ratio (INR) <1.7 or prothrombin time prolongation ≤4 seconds; b) Liver function: ALT/AST ≤5× upper limit of normal (ULN); Total bilirubin ≤210 μmol/L [≤2.38 mg/dL]; Albumin ≥28 g/L; c) Renal function: Serum creatinine ≤1.5× ULN.
Who cannot join
- Concurrent presence of other malignant tumors besides HCC;
- Moderate to severe ascites (ascites scoring 3 points on the Child-Pugh scale); - - Receipt of other first-line, second-line, or third-line systemic therapies (including any regimen of systemic treatment) or any local therapies (including transcatheter interventional therapy, ablation therapy, internal/external radiotherapy, etc.), as well as surgical resection or herbal medicine within 4 weeks prior to TACE combined with targeted immunotherapy;
- Incomplete data, such as missing baseline laboratory test results, unavailable or poor-quality imaging data, or lack of prognostic information;
- Severe liver dysfunction: e.g., decompensated cirrhosis or other liver diseases significantly affecting bilirubin levels;
- Severe comorbidities: e.g., refractory hypertension (blood pressure remaining above 150/100 mm Hg despite optimal medication), persistent arrhythmia (CTCAE grade 2 or higher), atrial fibrillation of any degree, prolonged QTc interval (>450 ms in males or >470 ms in females), renal insufficiency, etc.;
- Co-infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
- Pregnant or breastfeeding women;
- Acute or chronic psychiatric disorders (including those affecting participant enrollment, treatment intervention, or follow-up).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Generative Model-based System for Predicting Survival and Guiding Treatment Decisions in Patients With Unresectable Hepatocellular Carcinoma Undergoing Transarterial Chemoembolization in Combination With Immunotherapy and Targeted Therapy
The entry point of this study is the proposition of "generative longitudinal prediction," which utilizes only pre-treatment imaging to create high-fidelity predictions of post-treatment imaging. This approach effectively overcomes the clinical challenge of acquiring genuine longitudinal follow-up data. This paradigm shift not only tackles the scarcity of longitudinal data but also introduces an innovative method for treatment simulation using digital twins. Clinicians can intuitively assess the potential efficacy of various treatment plans before intervention through virtually generated multi-timepoint imaging, providing a visual foundation for personalized treatment decisions. This research merges generative AI with dynamic risk models to achieve: 1) a transition from static assessment to dynamic simulation; 2) earlier survival predictions; and 3) personalized optimization of treatment plans. By eliminating dependence on longitudinal data, we aim to deliver more precise and individualized treatment decision support for advanced liver cancer patients, ultimately enhancing survival outcomes and quality of life.
Read the detailed description
The entry point of this study is the proposition of "generative longitudinal prediction," which utilizes only pre-treatment imaging to create high-fidelity predictions of post-treatment imaging. This approach effectively overcomes the clinical challenge of acquiring genuine longitudinal follow-up data. This paradigm shift not only tackles the scarcity of longitudinal data but also introduces an innovative method for treatment simulation using digital twins. Clinicians can intuitively assess the potential efficacy of various treatment plans before intervention through virtually generated multi-timepoint imaging, providing a visual foundation for personalized treatment decisions. This research merges generative AI with dynamic risk models to achieve: 1) a transition from static assessment to dynamic simulation; 2) earlier survival predictions; and 3) personalized optimization of treatment plans. By eliminating dependence on longitudinal data, we aim to deliver more precise and individualized treatment decision support for advanced liver cancer patients, ultimately enhancing survival outcomes and quality of life. The model was developed in a retrospective cohort, with validation and testing conducted in multiple retrospective and prospective cohorts, respectively.
- Being tested
- Generative model
- Keywords
- hepatocellular carcinoma, gengerative model, transcatheter arterial chemoembolization, immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generative modelOther
Prospectively enroll pretreatment imaging data from patients with unresectable hepatocellular carcinoma undergoing TACE in combination with immunotherapy plus targeted therapy. Utilize a generative model to create virtual images that represent optimal treatment responses, and compare these virtual images with actual treatment response images collected during follow-up to evaluate the reliability of the generative model.
| Study group | Role | What they receive |
|---|---|---|
| development cohort, validation cohort, test cohort | Not described Receives: Other: Generative model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
defined as the time from the initial of combined therapy to death from any cause
Measured: Through study completion, an average of 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Arterial ChemoembolizationStudies 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
- Other
- Enrolment
- 550 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065786
- Sponsor's protocol ID
- GenTI-uHCC
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Generative Model-based System for Predicting Survival and Guiding Treatment Decisions in Patients With Unresectable Hepatocellular Carcinoma Undergoing Transarterial Chemoembolization in Combination With Immunotherapy and Targeted Therapy
- ClinicalTrials.gov ID
- NCT07065786
- Acronym / sponsor ID
- GenTI-uHCC
- Keywords
- hepatocellular carcinoma, gengerative model, transcatheter arterial chemoembolization, immunotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 15 Jul 2025 (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 entry point of this study is the proposition of "generative longitudinal prediction," which utilizes only pre-treatment imaging to create high-fidelity predictions of post-treatment imaging. This approach effectively overcomes the clinical challenge of acquiring genuine longitudinal follow-up data. This paradigm shift not only tackles the scarcity of longitudinal data but also introduces an innovative method for treatment simulation using digital twins. Clinicians can intuitively assess the potential efficacy of various treatment plans before intervention through virtually generated multi-timepoint imaging, providing a visual foundation for personalized treatment decisions. This research merges generative AI with dynamic risk models to achieve: 1) a transition from static assessment to dynamic simulation; 2) earlier survival predictions; and 3) personalized optimization of treatment plans. By eliminating dependence on longitudinal data, we aim to deliver more precise and individualized treatment decision support for advanced liver cancer patients, ultimately enhancing survival outcomes and quality of life.
Detailed description
The entry point of this study is the proposition of "generative longitudinal prediction," which utilizes only pre-treatment imaging to create high-fidelity predictions of post-treatment imaging. This approach effectively overcomes the clinical challenge of acquiring genuine longitudinal follow-up data. This paradigm shift not only tackles the scarcity of longitudinal data but also introduces an innovative method for treatment simulation using digital twins. Clinicians can intuitively assess the potential efficacy of various treatment plans before intervention through virtually generated multi-timepoint imaging, providing a visual foundation for personalized treatment decisions. This research merges generative AI with dynamic risk models to achieve: 1) a transition from static assessment to dynamic simulation; 2) earlier survival predictions; and 3) personalized optimization of treatment plans. By eliminating dependence on longitudinal data, we aim to deliver more precise and individualized treatment decision support for advanced liver cancer patients, ultimately enhancing survival outcomes and quality of life. The model was developed in a retrospective cohort, with validation and testing conducted in multiple retrospective and prospective cohorts, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| development cohort, validation cohort, test cohort | – | Other: Generative model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresectable hepatocellular carcinoma undergoing TACE in combination with immunotherapy plus targeted therapy
Key inclusion criteria (7 listed)
- Diagnosed as unresectable hepatocellular carcinoma (HCC) by histopathology and/or clinical diagnosis (typical imaging features, clinical manifestations, laboratory tests, etc.) (Reference: Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition));
- Patients with unresectable HCC receiving TACE combined with targeted immunotherapy;
- Liver function classified as Child-Pugh A or B;
- Aged 18 or above, regardless of gender;
- Expected survival time ≥3 months;
Key exclusion criteria (8 listed)
- Concurrent presence of other malignant tumors besides HCC;
- Moderate to severe ascites (ascites scoring 3 points on the Child-Pugh scale); - - Receipt of other first-line, second-line, or third-line systemic therapies (including any regimen of systemic treatment) or any local therapies (including transcatheter interventional therapy, ablation therapy, internal/external radiotherapy, etc.), as well as surgical resection or herbal medicine within 4 weeks prior to TACE combined with targeted immunotherapy;
- Incomplete data, such as missing baseline laboratory test results, unavailable or poor-quality imaging data, or lack of prognostic information;
- Severe liver dysfunction: e.g., decompensated cirrhosis or other liver diseases significantly affecting bilirubin levels;
- Severe comorbidities: e.g., refractory hypertension (blood pressure remaining above 150/100 mm Hg despite optimal medication), persistent arrhythmia (CTCAE grade 2 or higher), atrial fibrillation of any degree, prolonged QTc interval (>450 ms in males or >470 ms in females), renal insufficiency, etc.;
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 |
|---|---|---|
| Generative modelProspectively enroll pretreatment imaging data from patients with unresectable hepatocellular carcinoma undergoing TACE in combination with immunotherapy plus targeted therapy. Utilize a generative model to create virtual images that represent optimal treatment responses, and compare these virtual images with actual treatment response images collected during follow-up to evaluate the reliability of the generative model. | Other | development cohort, validation cohort, test cohort |
Primary outcome
Overall survival
Time frame: Through study completion, an average of 20 months
defined as the time from the initial of combined therapy to death from any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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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 Transcatheter Arterial Chemoembolization and Unresectable Hepatocellular Carcinoma, run by Zhongda Hospital 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: Through study completion, an average of 20 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 15 Jul 2025.