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NCT Number: NCT06298123

Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma: Risk Factor Analysis and Prognostic Modelling

The aim of this study was to analyse the independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after liver resection surgery, and to develop a prognostic model based on these factors.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Adjuvant Immunotherapy Carcinoma Carcinoma, Hepatocellular Checkpoint Inhibitor Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

By retrospectively collecting patient data from a single centre of liver surgery at Tongji Hospital between February 2019 and February 2023, the study aimed to comprehensively evaluate patients' demographic characteristics, oncological parameters, surgical details and response to immunotherapy to identify the key factors affecting postoperative recurrence and survival.

Who can participate

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

Inclusion criteria

  • HCC confirmed by pathologists
  • Undergone a curative resection (R0)
  • Aged 18-75 years
  • No previous systematic treatment and locoregional therapy for HCC prior to randomization
  • Absence of major macrovascular invasion
  • No extrahepatic spread

Exclusion criteria

  • Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma or recurrent HCC
  • Any preoperative treatment for HCC including local and systemic therapy
  • Unable to receive adjuvant therapy due to surgery-related complications, acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
  • incomplete clinical data

Treatment and study plan

Anti-PD-1 monoclonal antibody

Drug

The independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after hepatic resection surgery were analysed by retrospectively collecting patient data from the Centre for Liver Surgery, Tongji Hospital, during the period of February 2019 to February 2023, and comprehensively evaluating the patients' demographic characteristics, oncological parameters, surgical details, and response to immunotherapy, and establishing a prognostic model based on these factors.

Other names: Prognostic analysis

Primary outcomes

  1. Recurrence-Free Survival (RFS)

    Time frame: 2019-2023

    RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 2019-2023

    OS is defined as the time from randomization to death from any cause

Other outcomes

  1. Imaging data (enhanced CT and MRI） and histopathology data, if available.

    Time frame: 2019-2023

    Pre-surgical imaging data will be collected for machine learning to synthesise imaging features prognostic factors.

Sponsors and collaborators

Lead sponsor

Chen Xiaoping

Other

Registry information

Official study title

Risk Factor Analysis and Prognostic Modelling of Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2024
Registry last updated
Mar 7, 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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