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
1 other identifier
observational
304
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedMarch 7, 2024
March 1, 2024
4 years
March 1, 2024
March 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence-Free Survival (RFS)
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 Outcomes (1)
Overall Survival (OS)
2019-2023
Other Outcomes (1)
Imaging data (enhanced CT and MRI） and histopathology data, if available.
2019-2023
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chen Xiaopinglead
Study Sites (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 1, 2024
First Posted
March 7, 2024
Study Start
February 1, 2019
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
March 7, 2024
Record last verified: 2024-03