A New Conception About Individualized Treatment Allocation for HCC (PTA4HCC)

A New Conception About Individualized Treatment Allocation for HCC-Using Machine Learning

The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic stratification strategies to guide therapeutic allocation; however, the current guidelines did not consider the simultaneous comparison of distinct therapies in similar populations. Here, the investigators aimed to develop and validate a new, integrated prognostic scheme for HCC patients using artificial intelligence (AI) to simulate the survival outcomes of patients allocated to different treatments.

Study Overview

• Status: Completed
• Conditions: HCC; Resection; Transarterial Chemoembolization
• Intervention / Treatment: Procedure: TACE

Detailed Description

Given that liver resection (LR) and transarterial chemoembolization (TACE) are the mainstay curative and palliative therapies for HCC, respectively, patients who underwent LR or TACE were included in the study. Various prognostic AI algorithms were modeled using data from a large multi-institutional cohort, where LR and TACE were considered independent factors. The C-index, Brier score (BS), and area under the receiver operating characteristic curve (auROC) were calculated to estimate the AI models.

• Study Type: Observational
• Enrollment (Actual): 4991

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Between January 2010 and October 2021, a total of 4991 consecutive HCC patients receiving LR or TACE from 15 Chinese tertiary hospitals were retrospectively screened. HCC was diagnosed based on either imaging or pathological results as previously described

Description

Inclusion Criteria

• Diagnosed with HCC
• Receiving LR or TACE therapy
• Complete clinical information
• Preserved liver function (Child-Pugh Score [CPS] ≤ 7)
• PS 0-1

Exclusion Criteria

• Vascular invasion or extrahepatic spread;
• Ecompensated liver cirrhosis ;
• Younger than 18 years;
• Duration of follow-up of fewer than 30 days.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TACE group; Incorporated HCC patients underwent TACE therapy.	Procedure: TACE
Liver resection group; Incorporated HCC patients underwent liver resection therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	Overall survival (OS) was defined as the time interval between initial TACE or LR and all-cause death. Patients who survived up to the last follow-up date	5 years

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Collaborators: Xijing Hospital; Sun Yat-sen University; Shaanxi Provincial People's Hospital; Air Force Military Medical University, China; Health Science Center of Xi'an Jiaotong University; The First Affiliated Hospital of Shanxi Medical University; Army Medical University
• Investigators: Study Director: Lei Liu, doctor, Tangdu Hospital, Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: liulei

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No