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

March 1, 2024 updated by: Chen Xiaoping

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma (HCC) who underwent radical hepatectomy with adjuvant immunotherapy at the Liver Surgery Centre of Tongji Hospital between February 2019 and February 2023.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2019-2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 2019-2023
OS is defined as the time from randomization to death from any cause
2019-2023

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2019-2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen Xiaoping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • adjuvant-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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