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临床试验/NCT05543304
NCT05543304Enrolling By Invitation不适用

Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC) Based on Clinical Variables and Radiomics Data With Machine Learning Methods

First Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年12月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gang Chen, MD

Clinical Professor, Principal Investigator

First Affiliated Hospital of Wenzhou Medical University

研究点 (1)

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