Adjuvant Immunotherapy, Checkpoint Inhibitor, Hepatocellular Carcinoma
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-Free Survival (RFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 2019-2023 | OS is defined as the time from randomization to death from any cause |
Other
| Measure | Time frame | Description |
|---|---|---|
| Imaging data (enhanced CT and MRI) and histopathology data, if available. | 2019-2023 | Pre-surgical imaging data will be collected for machine learning to synthesise imaging features prognostic factors. |
Countries
China