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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Progression-Free Survival (PFS) | To analyse the Progression-Free Survival (PFS) of patients | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Secondary Clinical Endpoints - Overall Growth Phase (OS) | To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients | Up to approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yong Xu, Dr | Shenzhen Third People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Third People's Hospital | Shenzhen | Guangdong | 518112 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D058990 | Molecular Targeted Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Formalin-fixed, paraffin-embedded (FFPE) pathological tissue slides from tumor samples
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| D008107 |
| Liver Diseases |