Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma Stage III
• Intervention / Treatment: Procedure: Hepatectomy

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Chuan Pang; Phone Number: 18910527022; Email: pcpang117@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Ping Liang, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients pathologically diagnosed with hepatocellular carcinoma and underwent curative-intent hepatectomy

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

· Not meeting any one of the inclusion criteria or being unwilling/unable to follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TYPE I; Gross classification of resected specimen: single nodule with distinct margin, usually round with complete tumour envelope	Procedure: Hepatectomy; According to guideline recommended procedure of hepatectomy
TYPE II; Gross classification of resected specimen: single nodule with extranodular growth, no more than three extranodular points	Procedure: Hepatectomy; According to guideline recommended procedure of hepatectomy
TYPE III; Gross classification of resected specimen: a unifocal lesion composed of confluent multiple nodules, distinct boundaries among the nodules	Procedure: Hepatectomy; According to guideline recommended procedure of hepatectomy
TYPE IV; Gross classification of resected specimen: infiltrative nodule, with poor demarcated boundary and especially multiple extranodular points	Procedure: Hepatectomy; According to guideline recommended procedure of hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Prognosis; Imaging; Hepatocellular Carcinoma; Gross classification
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: S2024-423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No