A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data

Xuhua Duan

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Systemic therapy; Procedure: Interventional therapy

Study type: Observational

Funder types: Other

Identifiers

NCT07156617

2025-KY-1142-002

Details and patient eligibility

About

The system assesses the heterogeneity of HCC patients in terms of therapeutic outcomes (such as rwPFS, ORR, PRO) and adverse reactions during the process of interventional therapy combined with systemic treatment. It explores the clinical characteristics and biomarker levels of patients related to heterogeneity and builds a machine learning model to predict the risk of adverse reactions, providing evidence support for the construction of a patient-centered individualized decision-making system.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age ≥ 18 years old, gender not restricted; 2. Diagnosed with HCC through pathological or imaging examination, and meeting the diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)"; 3. Has received or plans to receive interventional therapy combined with systemic treatment (including but not limited to DEB-TACE combined with targeted therapy, DEB-TACE combined with targeted therapy and immunotherapy, DEB-TACE combined with targeted therapy and immunotherapy other local interventional treatments (such as HAIC, ablation, particle implantation, etc.)); 4. Has completed baseline clinical information and treatment records, can cooperate with the follow-up arrangement, and has the willingness and ability to complete the entire research process; 5. Signed the informed consent form.

Exclusion criteria

• 1. Diagnosed with liver metastatic cancer or other primary malignant tumors that are not HCC, or with concurrent other active primary malignant tumors; 2. Clearly have severe cognitive impairment, mental illness or confusion, and are unable to cooperate with the visit or fill out the scale; 3. Expected survival period is less than 3 months or clinical judgment indicates that follow-up cannot be completed; 4. Liver function is in decompensation, with Child-Pugh classification as C; 5. The investigator considers any other situation that is not suitable for participating in this study.

Trial design

2,000 participants in 1 patient group

Interventional therapy combined with systemic therapy

Description:

Interventional therapy combined with systemic therapy is divided into three subgroups, including 1)DEB-TACE in Combination with Targeted Therapy；2） DEB-TACE in Combination with Targeted Therapy and Immunotherapy；3）DEB-TACE in Combination with Targeted Therapy, Immunotherapy, and Other Interventional Therapies.

Treatment:

Procedure: Interventional therapy

Drug: Systemic therapy