A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data
1 other identifier
observational
2,000
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2025
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2025
CompletedFirst Posted
Study publicly available on registry
September 5, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
September 5, 2025
August 1, 2025
2 years
August 28, 2025
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rwPFS
The definition of rwPFS is the time from the first administration of combined therapy to the first imaging assessment indicating tumor progression or death, whichever occurs first.
up to 2 years
Secondary Outcomes (5)
ORR
up to 2 years
rwOS
up to2years
rwTTP
up to2years
PRO
up to2years
AE
up to2years
Study Arms (1)
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.
Interventions
Interventional therapy
Targeted Therapy drugs include but are not limited to Lenvatinib, Apatinib, etc. Immunotherapy drugs include but are not limited to Camrelizumab, Tislelizumab
Eligibility Criteria
Hepatocellular carcinoma
You may qualify if:
- \. 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.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xuhua Duanlead
Study Sites (14)
The Second Affiliated Hospital of Hainan Medical Universsity
Haikou, Hainan, China
Xingtai No.5 Hospital
Xingtai, Hebei, China
Deng zhou People's Hospital
Dengzhou, Henan, China
The Second People's Hospital of Jiaozuo
Jiaozuo, Henan, China
Huai He Hospital of Henan University
Kaifeng, Henan, China
Luo Yang Central Hospital
Luoyang, Henan, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
First People's Hospital of Shangqiu
Shangqiu, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhou Kou Central Hospital
Zhoukou, Henan, China
Wuxi No.5 People's Hospital
Wuxi, Jiangsu, China
Jiangxi Provincial People's Hospitail
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Second People's Hospital of Jiaozuo
Jiaozuo, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- The First Affiliated Hospital of Zhengzhou University
Study Record Dates
First Submitted
August 28, 2025
First Posted
September 5, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2028
Last Updated
September 5, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share