Trajectory-Based Prognostic Modeling in Hepatocellular Carcinoma

NCT ID: NCT07204262

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 379 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2024-11-01

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.

Conditions

Liver Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Molecular Targeted Therapy (TKI / anti-VEGF antibody) PD-(L)1 Inhibitor Immunotherapy Interventional Therapy (TACE / HAIC)

Intervention Type: 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).

Interventions

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).

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xu Yong, MD

OTHER

Sponsor Role: lead

Responsible Party

Xu Yong, MD

Secretary of the Party Committee & Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yong Xu, Dr

Role: STUDY_CHAIR

Shenzhen Third People's Hospital

Locations

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

KY2024-179

Identifier Type: -

Identifier Source: org_study_id