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NCT Number: NCT06559761

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Ping Liang, Doctor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hepatectomy

Procedure

According to guideline recommended procedure of hepatectomy

Primary outcomes

  1. Overall survival

    Time frame: 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 outcomes

  1. Disease-free survival

    Time frame: 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

  2. Imaging features

    Time frame: through study completion, an average of 1 year

    MRI or ultrasound Imaging features of the four types

  3. Quantification of immune cells of the resected liver tumour

    Time frame: 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

  4. mRNA sequencing data of the resected liver tumour and peritumor parenchyma

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chuan Pang

CONTACT

[email protected]

18910527022

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • The First Hospital of Jilin University

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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