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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06298123
• Other study ID #: adjuvant-03
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Checkpoint Inhibitor
• Hepatocellular Carcinoma

Intervention

Drug:
• Anti-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.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chen Xiaoping

Country where clinical trial is conducted

China, 

Outcome

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