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

Completed

• Conditions: Hepatocellular Carcinoma; Adjuvant Immunotherapy; Checkpoint Inhibitor

• Registration Number: NCT06298123
• Lead Sponsor: Chen Xiaoping

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall Survival (OS)	2019-2023	OS is defined as the time from randomization to death from any cause

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China