跳至主要内容
临床试验/NCT07495735
NCT07495735招募中不适用

Intelligence System for Predicting Atezolizumab-Bevacizumab Response and Clinical Outcomes in Unresectable Hepatocellular Carcinoma

First Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Objective response rate

研究概览

简要总结

This study is a multicenter retrospective clinical research, led by the First Affiliated Hospital of Wenzhou Medical University, and jointly conducted by other sub-centers. The aim is to develop an non-invasive artificial intelligence system for predicting the response and clinical outcomes of patients with unresectable hepatocellular carcinoma (uHCC) to the treatment with atezolizumab combined with bevacizumab (T+A). In response to the clinical situation where approximately half of uHCC patients do not respond to the standard T+A therapy and traditional invasive biopsy is unable to fully reflect the heterogeneity of the tumor microenvironment, this study plans to retrospectively collect the data of 400 patients who met the inclusion and exclusion criteria from January 2020 to November 2025. The study will systematically summarize multi-dimensional data such as enhanced CT images within one month before treatment, baseline characteristics, serum markers, liver disease factors, and tumor stage. By integrating these clinical features with deep learning imageomics features extracted from images, the research team is dedicated to constructing and validating a safe, non-invasive, and reproducible prediction model, with the aim of achieving precise identification of the benefit population before implementing immunotherapy combined with anti-angiogenic treatment, and providing a powerful intelligent tool support for optimizing clinical treatment decisions and improving patient survival prognosis.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (i) Clinical or pathological diagnosis of HCC;
  • (ii) Administration of atezolizumab-bevacizumab treatment;
  • (iii) At least 18 years old.

排除标准

  • (i) Lack of key clinical data (laboratory test results), or lack of enhanced CT images taken within one month before treatment;
  • (ii) Comorbid with other malignant tumors;
  • (iii) PS score > 2 or Child-Pugh score > 7;
  • (iv) Unable to evaluate tumor response;
  • (v) Loss to follow-up.

结局指标

主要结局

Objective response rate

时间窗: through study completion, an average of 1 year

次要结局

未报告次要终点

研究者

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

Gang Chen, MD

Director of Hepatobiliary Surgery, Clinical Professor, Vice President

First Affiliated Hospital of Wenzhou Medical University

研究点 (1)

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