A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data
- Conditions
- Hepatocellular Carcinoma (HCC)
- Interventions
- Procedure: Interventional therapyDrug: Systemic therapy
- Registration Number
- NCT07156617
- Lead Sponsor
- Xuhua Duan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Interventional therapy combined with systemic therapy Interventional 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 combined with systemic therapy 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.
- Primary Outcome Measures
Name Time Method rwPFS up to 2 years 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.
- Secondary Outcome Measures
Name Time Method ORR up to 2 years ORR is defined as the proportion of patients who achieve complete remission (CR, Complete Response) and partial remission (PR, Partial Response) according to the mRECIST criteria.
rwOS up to2years The rwOS is defined as the time from the first administration of combined therapy to the occurrence of any cause of death. If there is no death record for the patient, the last visit time will be used as the censored value.
rwTTP up to2years The rwTTP is defined as the time from the first administration of combined therapy to the first imaging assessment revealing tumor progression.
PRO up to2years The PRO score includes the scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its liver cancer module (EORTC QLQ-HCC18) that were filled out by the patients themselves.
AE up to2years Adverse Event
Trial Locations
- Locations (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
Scroll for more (4 remaining)The Second Affiliated Hospital of Hainan Medical Universsity🇨🇳Haikou, Hainan, ChinaYong WangContact