Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research
- Conditions
- Hepatocellular Carcinoma Stage III
- Interventions
- Procedure: Hepatectomy
- Registration Number
- NCT06559761
- Lead Sponsor
- Chinese PLA General Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- According to the WHO classification, the pathological diagnosis is hepatocellular carcinoma.
- The initial treatment is curative-intent hepatectomy.
- There is no evidence of major vascular/hepatic portal invasion, extrahepatic/lymph node metastasis, or other malignant tumors.
- Age 18-80 years old.
· Not meeting any one of the inclusion criteria or being unwilling/unable to follow-up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TYPE I Hepatectomy Gross classification of resected specimen: single nodule with distinct margin, usually round with complete tumour envelope TYPE II Hepatectomy Gross classification of resected specimen: single nodule with extranodular growth, no more than three extranodular points TYPE III Hepatectomy Gross classification of resected specimen: a unifocal lesion composed of confluent multiple nodules, distinct boundaries among the nodules TYPE IV Hepatectomy Gross classification of resected specimen: infiltrative nodule, with poor demarcated boundary and especially multiple extranodular points
- Primary Outcome Measures
Name Time Method Overall survival through study completion, an average of 1 year OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
- Secondary Outcome Measures
Name Time Method Disease-free survival through study completion, an average of 1 year DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier
mRNA sequencing data of the resected liver tumour and peritumor parenchyma through study completion, an average of 1 year mRNA sequencing data of the resected liver tumour and peritumor parenchyma specimen to assess the gene enrichment
Imaging features through study completion, an average of 1 year MRI or ultrasound Imaging features of the four types
Quantification of immune cells of the resected liver tumour through study completion, an average of 1 year 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
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China