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Trajectory-Based Prognostic Modeling in Hepatocellular Carcinoma

Integrating Longitudinal Biomarker Dynamics With Clinical Features for Prognostic Prediction in Hepatocellular Carcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07204262
Enrollment
379
Registered
2025-10-02
Start date
2018-01-01
Completion date
2024-11-01
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Brief 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). 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.

Interventions

COMBINATION_PRODUCTMolecular 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).

Sponsors

Xu Yong, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. pathologically or radiologically confirmed HCC; 2. availability of pre- treatment clinical record, radiological and hematological data and more than 2 cycles of post-treatment data; 3. receipt of treatment during the study period; 4. Age rather than 18 years old.

Exclusion criteria

1. baseline data missed; 2. Non-primary liver cancer; 3. incomplete follow-up data; 4. Unevaluable lesions.

Design outcomes

Primary

MeasureTime frameDescription
Objective Progression-Free Survival (PFS)Up to approximately 3 yearsTo analyse the Progression-Free Survival (PFS) of patients

Secondary

MeasureTime frameDescription
Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)Up to approximately 3 yearsTo analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026