Radiomics-based Unsupervised Machine Learning Model to Identify Responders to Transarterial Chemoembolization Versus Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: a Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The goal of this observational study is to learn about the efficacy of Transarterial Chemoembolization (TACE) versus Hepatic Arterial Infusion Chemotherapy (HAIC) in patients with unresectable hepatocellular carcinoma (HCC). The main questions it aims to answer are:
Can distinct imaging phenotype subtypes be identified in unresectable HCC patients using radiomics and unsupervised clustering?
Do these different imaging subtypes show significant differences in treatment efficacy (such as objective response rate, progression-free survival, and overall survival) after receiving TACE or HAIC?
Can this method objectively identify which imaging subtype of patients is more suitable for TACE and which may benefit more from HAIC?
Participants in this study are adult patients diagnosed with unresectable HCC (BCLC stage B or C) who have already undergone complete TACE or HAIC treatment as part of their regular medical care between January 2015 and December 2024. Researchers will retrospectively analyze their existing clinical data and pre-treatment medical images to compare outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria;
- •Barcelona Clinic Liver Cancer (BCLC) stage B or C, assessed as unresectable by surgical evaluation;
- •Received either TACE or HAIC as the sole interventional treatment modality throughout the treatment course (no crossover between the two modalities allowed);
- •Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment;
- •Performance status (PS) score of 0 or 1.
排除标准
- •Patients with an unclear diagnosis or those with concurrent other malignant tumors;
- •Liver function classified as Child-Pugh Class C or worse, which cannot be improved after hepatoprotective treatment;
- •Patients with severe infections, such as respiratory, biliary tract, or abdominal infections;
- •Patients with severe underlying diseases, particularly immune-related disorders.
- •Patients with severely incomplete or missing baseline or outcome data.
研究组 & 干预措施
TACE group
Patients with unresectable HCC treated with transarterial chemoembolization
干预措施: Transarterial chemoembolization (TACE) (Procedure)
HAIC group
Patients with unresectable HCC treated with hepatic arterial infusion chemotherapy
干预措施: hepatic arterial infusion chemotherapy (HAIC) (Procedure)
结局指标
主要结局
Overall survival
时间窗: From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months
Time interval from date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months
次要结局
- Progression free survival(From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Tumor response(From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
研究者
Wenzhe Fan
Professor
First Affiliated Hospital, Sun Yat-Sen University