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

NCT ID: NCT07156617

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2028-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Interventional therapy combined with systemic therapy

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.

Interventional therapy

Intervention Type PROCEDURE

Interventional therapy

Systemic therapy

Intervention Type DRUG

Targeted Therapy drugs include but are not limited to Lenvatinib, Apatinib, etc. Immunotherapy drugs include but are not limited to Camrelizumab, Tislelizumab

Interventions

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Interventional therapy

Interventional therapy

Intervention Type PROCEDURE

Systemic therapy

Targeted Therapy drugs include but are not limited to Lenvatinib, Apatinib, etc. Immunotherapy drugs include but are not limited to Camrelizumab, Tislelizumab

Intervention Type DRUG

Other Intervention Names

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Targeted Therapy Immunotherapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuhua Duan

OTHER

Sponsor Role lead

Responsible Party

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Xuhua Duan

The First Affiliated Hospital of Zhengzhou University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Second Affiliated Hospital of Hainan Medical Universsity

Haikou, Hainan, China

Site Status

Xingtai No.5 Hospital

Xingtai, Hebei, China

Site Status

Deng zhou People's Hospital

Dengzhou, Henan, China

Site Status

The Second People's Hospital of Jiaozuo

Jiaozuo, Henan, China

Site Status

Huai He Hospital of Henan University

Kaifeng, Henan, China

Site Status

Luo Yang Central Hospital

Luoyang, Henan, China

Site Status

The First Affiliated Hospital of Henan University of science and Technology

Luoyang, Henan, China

Site Status

First People's Hospital of Shangqiu

Shangqiu, Henan, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Zhou Kou Central Hospital

Zhoukou, Henan, China

Site Status

Wuxi No.5 People's Hospital

Wuxi, Jiangsu, China

Site Status

Jiangxi Provincial People's Hospitail

Nanchang, Jiangxi, China

Site Status

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

Second People's Hospital of Jiaozuo

Jiaozuo, , China

Site Status

Countries

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China

Central Contacts

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Xuhua Duan

Role: CONTACT

+8613523402912

Facility Contacts

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Yong Wang

Role: primary

Menglong Li

Role: primary

Yanliang Li

Role: primary

Chuntang Qin

Role: primary

Xiang He

Role: primary

Fazhong Li

Role: primary

Huanzhang Niu

Role: primary

18567635732

Zhenhua Tian

Role: primary

Xuhua Duan

Role: primary

13523402912

Role: backup

Cheng Xing

Role: primary

Shihua Luo

Role: primary

Chuntang Qin

Role: primary

Other Identifiers

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2025-KY-1142-002

Identifier Type: -

Identifier Source: org_study_id

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