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

Chen Xiaoping1 site in 1 country304 target enrollmentFebruary 1, 2019

ConditionsHepatocellular Carcinoma Adjuvant Immunotherapy Checkpoint Inhibitor

DrugsAnti-PD-1 monoclonal antibody

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Chen Xiaoping
Enrollment: 304
Locations: 1
Primary Endpoint: Recurrence-Free Survival (RFS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2019

End Date

February 1, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Chen Xiaoping

Responsible Party

Sponsor Investigator

Principal Investigator

Chen Xiaoping

Professor

Tongji Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).