Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research
NCT Number: NCT06559761
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma Stage III
Interventions: PROCEDURE: Hepatectomy
Sponsor: Chinese PLA General Hospital
Collaborators: The First Hospital of Jilin University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2029-12-31
Locations: Chinese PLA General Hospital, Beijing, Beijing, 100853, China

Summary:
Hepatocellular carcinoma (HCC) is a highly heterogeneous malignant tumor with significant differences in invasion, proliferation ability and patient prognosis. Currently, there is a lack of non-invasive and simple indicators to predict the prognosis of HCC patients and assist clinical decision-making. The identification of HCC macroscopic or histopathological classification requires large pathological specimens obtained through surgical resection, but only about 20% of patients are eligible for surgical treatment. Moreover, most liver cancer diagnoses can be confirmed by imaging examinations without relying on pathological results. For patients who have not undergone surgical resection, the lack of histopathological information during treatment means that there is no basis for judging tumor proliferation and obtaining rich prognostic information. Therefore, evaluating the invasion and proliferation ability of HCC based on macroscopic imaging assessment has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.

Ultrasound and MRI are ideal entry points as first-line imaging methods for liver cancer diagnosis. This study aims to evaluate HCC macroscopic or histopathological classification based on multimodal imaging (ultrasound, CT, MRI), thereby assessing its invasion and proliferation ability which has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.

By analyzing macroscopic image features we aim to explore their cross-scale correlations with HCC macroscopic classification,histopathological classification,and gene molecular typing.

Primary Outcome Measures: Overall survival, OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death, through study completion, an average of 1 year
Secondary Outcome Measures: Disease-free survival, DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier, through study completion, an average of 1 year|Imaging features, MRI or ultrasound Imaging features of the four types, through study completion, an average of 1 year|Quantification of immune cells of the resected liver tumour, Quantification of immune cells of the resected liver tumour using HE staining and immunohistological staining to assess molecular marker and cell infiltration in tumor and liver parenchyma, through study completion, an average of 1 year|mRNA sequencing data of the resected liver tumour and peritumor parenchyma, mRNA sequencing data of the resected liver tumour and peritumor parenchyma specimen to assess the gene enrichment, through study completion, an average of 1 year