Hepatocellular Carcinoma Clinical Trial
Official title:
Risk Factor Analysis and Prognostic Modelling of Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma
Verified date | March 2024 |
Source | Tongji Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 304 |
Est. completion date | February 1, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
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 |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Chen Xiaoping |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Imaging data (enhanced CT and MRI) and histopathology data, if available. | Pre-surgical imaging data will be collected for machine learning to synthesise imaging features prognostic factors. | 2019-2023 | |
Primary | 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 | Overall Survival (OS) | OS is defined as the time from randomization to death from any cause | 2019-2023 |
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