Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC) Based on Clinical Variables and Radiomics Data With Machine Learning Methods
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
As the most common type of primary liver cancer, hepatocellular carcinoma (HCC) has become a big challenge all over the world. Most patients are not available to curative resection when first diagnosed. There are a variety of treatment options for advanced HCC. However, due to the heterogeneity of HCC, the overall response rate (ORR) is not high for systemic therapies. Therefore, appropriate selection of patients who are suitable for individual systemic therapies is important for clinical decision-making.
详细描述
Although major achievements have been acquired in diagnosis and treatment, the prognosis of hepatocellular carcinoma (HCC) is still unsatisfactory. Liver resection remains the main curative treatment for HCC, but most patients are at an advanced stage when first diagnosed, leading to be not available to curative therapies. There is a variety of treatment options for advanced HCC, such as transarterial chemoembolization (TACE), hepatic artery infusion chemotherapy (HAIC), targeted therapy (sorafenib and lenvatinib), immunotherapy, and the combination of different therapies. However, due to the heterogeneity of HCC, different patients respond differently to systemic therapies. The the overall response rate (ORR) is not satisfactory and most patients can not benefit from the systemic therapies. There is an urgent need to identify patients who are likely to have positive response to systemic therapies at the beginning before treatment. Therefore ,we want to collect the clinical information of patients with advanced HCC treated with systemic therapies, including demographic data , laboratory index, histological features, radiomics data. Patients are followed-up at a interval of 1 month after treatment, and the ORR, overall survival (OS), progression-free survival (PFS) are recorded. Then the treatment response are evaluated and the relationship between the clinical data and efficacy of systemic therapies are explored by machine learning methods. Then models based on clinical features or radiomics features are developed to predict response to different systemic therapies.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically or pathologically diagnosed HCC
- •Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2
- •Child-Pugh score of ≤7
- •complete clinical and follow-up information
- •evaluable efficacy after treatment
- •age between 18-80 years old
排除标准
- •with other malignancies
- •Eastern Cooperative Oncology Group performance status (ECOG-PS) >2
- •Child-Pugh score of >7
- •incomplete clinical data
- •lost to follow up
- •unevaluable efficacy after treatment
- •age <18 years old or >80 years old
结局指标
主要结局
Objective response rate
时间窗: 3 months
Tumor response are evaluated to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
次要结局
- Overall survival(1 year)
- Progression free survival(1 year)
研究者
Gang Chen, MD
Clinical Professor, Principal Investigator
First Affiliated Hospital of Wenzhou Medical University
