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Construction and Clinical Validation of a Predictive Model for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Based on Whole-Slide Digital Pathological Images and Deep Learning

Second Affiliated Hospital, Zhejiang University, School of Medicine · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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hepatocellular-carcinoma-hcc
Hepatocellular carcinoma (HCC) is a high-mortality global malignancy with a heavy disease burden in China. Although curative surgical resection improves survival for early-stage HCC patients, the 5-year postoperative recurrence rate remains as high as 50%-70%. Postoperative adjuvant TACE and systemic TKIs are standard treatments for high-risk HCC, yet both therapies have prominent drawbacks, including limited response rates, unavoidable toxicities, and inconsistent clinical benefits. Current treatment decisions rely on conventional clinical and pathological features without precise biomarkers, leading to inadequate individualized therapy and wasted medical resources. Tumor immune microenvironment and multimodal imaging-pathological features critically determine HCC treatment sensitivity. Artificial intelligence and deep learning based on preoperative radiomics and postoperative H\&E whole-slide imaging (WSI) can capture hidden tumor biological characteristics and predict therapeutic responses. However, no validated multimodal AI model is available for predicting postoperative TACE and TKI treatment outcomes in HCC, lacking large-scale multicenter prospective evidence. This study aims to construct and validate a multimodal deep learning model integrating preoperative contrast-enhanced CT/MRI, postoperative WSI, pathological reports, and clinical data, to precisely identify HCC patients sensitive to postoperative adjuvant TACE or TKI therapy and optimize individualized treatment strategies. This is a hybrid retrospective-training and prospective observational multicenter study with no clinical intervention. A total of 10,000 retrospective HCC surgical patients will be enrolled to develop an AI classification model for predicting responses to four postoperative treatment strategies: surgery alone, surgery plus TACE, surgery plus TACE combined with systemic therapy, and surgery plus exclusive systemic therapy. Subsequently, 1,000 eligible postoperative HCC patients w
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