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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06298123
Enrollment
304
Registered
2024-03-07
Start date
2019-02-01
Completion date
2023-02-01
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvant Immunotherapy, Checkpoint Inhibitor, Hepatocellular Carcinoma

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.

Interventions

DRUGAnti-PD-1 monoclonal antibody

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.

Sponsors

Chen Xiaoping
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence-Free Survival (RFS)2019-2023RFS 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

MeasureTime frameDescription
Overall Survival (OS)2019-2023OS is defined as the time from randomization to death from any cause

Other

MeasureTime frameDescription
Imaging data (enhanced CT and MRI) and histopathology data, if available.2019-2023Pre-surgical imaging data will be collected for machine learning to synthesise imaging features prognostic factors.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026