A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 14
- 主要终点
- rwPFS
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age ≥ 18 years old, gender not restricted;
- •Diagnosed with HCC through pathological or imaging examination, and meeting the diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)";
- •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.));
- •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;
- •Signed the informed consent form.
排除标准
- •1. Diagnosed with liver metastatic cancer or other primary malignant tumors that are not HCC, or with concurrent other active primary malignant tumors;
- •Clearly have severe cognitive impairment, mental illness or confusion, and are unable to cooperate with the visit or fill out the scale;
- •Expected survival period is less than 3 months or clinical judgment indicates that follow-up cannot be completed;
- •Liver function is in decompensation, with Child-Pugh classification as C;
- •The investigator considers any other situation that is not suitable for participating in this study.
研究组 & 干预措施
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.
干预措施: Interventional therapy (Procedure)
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.
干预措施: Systemic therapy (Drug)
结局指标
主要结局
rwPFS
时间窗: 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.
次要结局
- ORR(up to 2 years)
- rwOS(up to2years)
- rwTTP(up to2years)
- PRO(up to2years)
- AE(up to2years)
研究者
Xuhua Duan
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Zhengzhou University