Liver CancerNCT07204262
Trajectory-Based Prognostic Modeling in Hepatocellular Carcinoma
An observational study of Liver Cancer, run by Xu Yong, MD at 1 site in China.
Trial summary
To evaluate whether tracking changes in key blood markers over time, together with clinical features, can improve the prediction of outcomes in patients with hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Molecular Targeted Therapy (TKI / anti-VEGF antibody) PD-(L)1 Inhibitor Immunotherapy Interventional Therapy (TACE / HAIC)
- Type of treatment
- Injection or infusion
- How many people
- 379 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Nov 2024
- 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 advanced hepatocellular carcinoma (HCC), age ≥18 years, with complete baseline and follow-up clinical, radiological, and laboratory data who received systemic or interventional therapy. Patients with non-primary liver cancer, missing data, incomplete follow-up, or unevaluable lesions were excluded.
Who may be able to join
- pathologically or radiologically confirmed HCC;
- availability of pre- treatment clinical record, radiological and hematological data and more than 2 cycles of post-treatment data;
- receipt of treatment during the study period;
- Age rather than 18 years old.
Who cannot join
- baseline data missed;
- Non-primary liver cancer;
- incomplete follow-up data;
- Unevaluable lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Longitudinal Biomarker Dynamics With Clinical Features for Prognostic Prediction in Hepatocellular Carcinoma
To evaluate whether tracking changes in key blood markers over time, together with clinical features, can improve the prediction of outcomes in patients with hepatocellular carcinoma (HCC). By developing a trajectory-based prognostic model, we aim to provide more accurate risk assessment and support personalized treatment decisions.
Read the detailed description
This study retrospectively analyzed patients with advanced hepatocellular carcinoma (HCC) who were treated at Shenzhen Third People's Hospital between 2018 and 2024. Eligible participants received systemic therapy with molecular targeted agents or PD-(L)1 inhibitors, with or without interventional procedures such as transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC).
Clinical, radiological, and laboratory data were collected at baseline and during follow-up. Blood tests were performed at regular intervals, and imaging evaluations with contrast-enhanced CT or MRI were conducted every 6-12 weeks in accordance with standard practice. Demographic information, disease stage, comorbidities, and treatment- or disease-related complications were also recorded.
The study focuses on the analysis of longitudinal biomarker changes, with the aim of developing prognostic models that integrate biomarker trajectories with clinical features. The ultimate goal is to improve dynamic risk stratification and support personalized treatment decisions for patients with HCC.
- Conditions
- Liver Cancer
- Being tested
- Molecular Targeted Therapy (TKI / anti-VEGF antibody) PD-(L)1 Inhibitor Immunotherapy Interventional Therapy (TACE / HAIC)
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Targeted Therapy (TKI / anti-VEGF antibody) PD-(L)1 Inhibitor Immunotherapy Interventional Therapy (TACE / HAIC)Combination product
Patients in this study received systemic therapy with molecular targeted agents, including tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies, and/or PD-(L)1 inhibitor immunotherapy. Some patients also received interventional therapies such as transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC). Treatment regimens, combinations, and sequencing were determined based on physician discretion and patient clinical status. This study focuses on the longitudinal monitoring of biomarkers during these therapies to evaluate their prognostic value and to develop a trajectory-based risk stratification model for advanced hepatocellular carcinoma (HCC).
| Study group | Role | What they receive |
|---|---|---|
| Advanced HCC Cohort | This cohort includes patients with advanced hepatocellular carcinoma (HCC) who received systemic therapy with molecular targeted agents (TKIs or anti-VEGF antibodies) and/or PD-(L)1 inhibitors, with or without interventional treatments such as transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC). Clinical, radiological, and laboratory data were collected retrospectively to evaluate longitudinal biomarker trajectories and construct prognostic models. Receives: Combination Product: Molecular Targeted Therapy (TKI / anti-VEGF antibody) PD-(L)1 Inhibitor Immunotherapy Interventional Therapy (TACE / HAIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Progression-Free Survival (PFS)
To analyse the Progression-Free Survival (PFS) of patients
Measured: Up to approximately 3 years
Secondary outcomes (1)
Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)
To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jan 2018
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xu Yong, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Yong, MD, Shenzhen Third People's Hospital
- Investigators
- Yong Xu, Dr, Study chair, Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204262
- Sponsor's protocol ID
- KY2024-179
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Longitudinal Biomarker Dynamics With Clinical Features for Prognostic Prediction in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07204262
- Acronym / sponsor ID
- KY2024-179
- Conditions
- Liver Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Xu Yong, MDUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 2 Oct 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.
To evaluate whether tracking changes in key blood markers over time, together with clinical features, can improve the prediction of outcomes in patients with hepatocellular carcinoma (HCC). By developing a trajectory-based prognostic model, we aim to provide more accurate risk assessment and support personalized treatment decisions.
Detailed description
This study retrospectively analyzed patients with advanced hepatocellular carcinoma (HCC) who were treated at Shenzhen Third People's Hospital between 2018 and 2024. Eligible participants received systemic therapy with molecular targeted agents or PD-(L)1 inhibitors, with or without interventional procedures such as transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC).
Clinical, radiological, and laboratory data were collected at baseline and during follow-up. Blood tests were performed at regular intervals, and imaging evaluations with contrast-enhanced CT or MRI were conducted every 6-12 weeks in accordance with standard practice. Demographic information, disease stage, comorbidities, and treatment- or disease-related complications were also recorded.
The study focuses on the analysis of longitudinal biomarker changes, with the aim of developing prognostic models that integrate biomarker trajectories with clinical features. The ultimate goal is to improve dynamic risk stratification and support personalized treatment decisions for patients with HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced HCC Cohort | – | Combination Product: Molecular Targeted Therapy (TKI / anti-VEGF antibody) PD-(L)1 Inhibitor Immunotherapy Interventional Therapy (TACE / HAIC)This cohort includes patients with advanced hepatocellular carcinoma (HCC) who received systemic therapy with molecular targeted agents (TKIs or anti-VEGF antibodies) and/or PD-(L)1 inhibitors, with or without interventional treatments such as transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC). Clinical, radiological, and laboratory data were collected retrospectively to evaluate longitudinal biomarker trajectories and construct prognostic models. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced hepatocellular carcinoma (HCC), age ≥18 years, with complete baseline and follow-up clinical, radiological, and laboratory data who received systemic or interventional therapy. Patients with non-primary liver cancer, missing data, incomplete follow-up, or unevaluable lesions were excluded.
Key inclusion criteria (4 listed)
- pathologically or radiologically confirmed HCC;
- availability of pre- treatment clinical record, radiological and hematological data and more than 2 cycles of post-treatment data;
- receipt of treatment during the study period;
- Age rather than 18 years old.
Key exclusion criteria (4 listed)
- baseline data missed;
- Non-primary liver cancer;
- incomplete follow-up data;
- Unevaluable lesions.
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 |
|---|---|---|
| Molecular Targeted Therapy (TKI / anti-VEGF antibody) PD-(L)1 Inhibitor Immunotherapy Interventional Therapy (TACE / HAIC)Patients in this study received systemic therapy with molecular targeted agents, including tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies, and/or PD-(L)1 inhibitor immunotherapy. Some patients also received interventional therapies such as transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC). Treatment regimens, combinations, and sequencing were determined based on physician discretion and patient clinical status. This study focuses on the longitudinal monitoring of biomarkers during these therapies to evaluate their prognostic value and to develop a trajectory-based risk stratification model for advanced hepatocellular carcinoma (HCC). | Combination product | Advanced HCC Cohort |
Primary outcome
Objective Progression-Free Survival (PFS)
Time frame: Up to approximately 3 years
To analyse the Progression-Free Survival (PFS) of patients
1 secondary outcome
Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)
Time frame: Up to approximately 3 years
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 2 Oct 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.
Yong Xu, Dr study chair
Shenzhen Third People's Hospital
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 Liver Cancer, run by Xu Yong, MD 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 4 inclusion and 4 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 2 Oct 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?
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?
Objective Progression-Free Survival (PFS) (time frame: Up to approximately 3 years). 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 2 Oct 2025.